|Home | About | Journals | Submit | Contact Us | Français|
Merck has announced the FDA’s approval of mometasone furoate/formoterol fumarate dihydrate (Dulera), a respiratory drug for asthma in patients 12 years of age and older; however, a boxed warning states that this agent can increase the risk of death.
This fixed-dose combination was developed by Schering-Plough and inherited by Merck last year. An inhaled corticosteroid is combined with a long-acting beta2-agonist (LABA). The drug’s approval was based, in part, on phase 3 studies showing significant improvement in lung function.
The FDA recently raised concerns about LABAs, requiring a boxed warning for fluticasone/salmeterol and salmeterol xinafoate (Advair Diskus and Serevent Diskus, both GlaxoSmithKline); formoterol (Foradil, Schering); and budesonide/formoterol (Symbicort, AstraZeneca). LABAs relax the muscles around stressed airways, but this can keep patients from noticing dangerous inflammation building up in the airways.
Patients should use LABAs only until asthma control is achieved; after that, they should gradually stop using them.
Sources: Drug Discov Dev, Fierce Bio-tech, and DailyFinance, June 24, 2010
The FDA has approved the first generic version of Wyeth’s Effexor XR capsules (venlafaxine HCl) to treat major depressive disorder. Teva is manufacturing the capsules in strengths of 37.5 mg, 75 mg, and 150 mg.
The prescribing label for the generic medication may differ from that of Effexor XR capsules because some uses of the drug and parts of the label are protected by patents that Wyeth holds. Generic venlafaxine HCl will have the same safety warnings as Effexor XR.
A boxed warning indicates that anti-depressant agents may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
Source: FDA, June 29, 2010
Mylan Pharmaceuticals has received final approval for its Abbreviated New Drug Application (ANDA) for nifedipine extended-release (XL) tablets USP, 30 mg, 60 mg, and 90 mg. This product is the generic version of Pfizer’s Procardia XL tablets, which are used for patients with angina, hypertension, or both.
Source: Mylan Inc., www.mylan.com, June 24, 2010
Final approval has been granted to Matrix Laboratories Ltd., a Mylan subsidiary, for its simvastatin tablets in strengths of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. The product is the generic version of Merck’s Zocor, a therapy for hypercholesterolemia.
Source: Mylan Inc., www.mylan.com, June 18, 2010
Several companies, including Mylan and Teva, have announced final approval of their generic versions of AstraZeneca’s Arimidex. The FDA approved 1-mg tablets of anastrozole, the active ingredient, to treat some types of breast cancer in postmenopausal women.
Anastrozole, a nonsteroidal, fourth-generation aromatase inhibitor, suppresses serum estradiol levels and offers an alternative to tamoxifen for hormone receptor–positive breast cancer.
Unlike aminoglutethimide (Cytadren, Novartis), an early aromatase inhibitor, anastrozole does not inhibit adrenal steroid synthesis, having no detectable effect on formation of adrenal corticosteroids or aldosterone.
Sources: Teva and Mylan, June 29, 2010
The FDA has approved a new three-in-one drug by Daiichi Sankyo for treating hypertension. Tribenzor is a once-daily treatment for inadequately controlled hypertension. Olmesartan (Benicar, Daiichi Sankyo) is an angiotensin-receptor blocker, amlodipine (Norvasc, Pfizer) is a calcium-channel blocker, and hydrochlorothiazide is a diuretic. More than two-thirds of patients need two or more agents to achieve control.
Sources: Hypertension 2010;55:399–407; Daiichi Sankyo, July 26, 2010
The FDA has approved Shire’s methylphenidate transdermal system (Daytrana) for the treatment of attention deficit/hyperactivity disorder (ADHD) in adolescents 13 to 17 years of age. The patch is already approved for ADHD in children 6 to 12 years of age. Daytrana has been licensed globally to Shire by Noven Pharmaceuticals.
The patch is best applied to the hip area two hours before an effect is required, and it should be removed nine hours after application. Effects can continue for several hours after the patch is removed. The patch can be removed before nine hours have elapsed if a shorter duration of effect is required.
Daytrana is sold in strengths of 10 mg, 15 mg, 20 mg, and 30 mg. The physician should titrate the dose to the desired effect.
A boxed warning mentions that Daytrana should be given cautiously to patients with a history of drug dependence or alcoholism. Careful supervision is required during withdrawal from abusive use because depression may occur. The patch is not indicated for patients who have an allergy to its components; marked anxiety, tension, or agitation; glaucoma; tics or a diagnosis of a family history of Tourette syndrome; or seizures. It is contraindicated for those taking monoamine oxidase inhibitors.
Adverse reactions have included erythema at the application site, decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, and anorexia in children. Decreased appetite, nausea, insomnia, decreased weight, dizziness, abdominal pain and anorexia have been reported in adolescents.
Stimulants should be avoided when patients have structural cardiac abnormalities, arrhythmias, cardiomyopathy, or coronary artery disease. Treatment should be discontinued if contact sensitization is suspected. Patients should not apply external heat to the patch.
Sources: Shire, www.shire.com; Drug Disc Dev, July 9, 2010.
Lacosamide (Vimpat, UCB), a controlled substance, is now available in a 10-mg/mL oral solution for the add-on treatment of partial-onset seizures in patients 17 years of age and older.
This product is also sold as oral tablets and as an intravenous (IV) injection. Patients can be switched between formulations—with equivalent dosing—without dose titration. The oral solution may be particularly useful for elderly patients with gastric tubes in place.
Adverse reactions have included dizziness, headache, nausea, and diplopia.
Source: The Medical News, June 14, 2010
Purdue Pharma LP has announced the approval of Butrans (buprenorphine) Transdermal System for the management of moderate-to-severe chronic pain in patients needing continuous, around-the-clock opioid analgesia for an extended period of time. This Schedule III analgesic agent is released continuously over a period of seven days.
Buprenorphine is a partial agonist at mu-opioid receptors and an antagonist at kappa-opioid receptors. Purdue has developed a Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide, Elements to Assure Safe Use.
The patch is available in strengths of 5, 10, and 20 mcg/hour. A single patch is worn for seven days. An application of 20 mcg/hour should not be exceeded because of the risk of prolongation of the corrected QT interval. The application site and surrounding area should not be exposed to direct external heat sources.
Butrans is contraindicated in patients who have severe bronchial asthma; who are taking class IA or III antiarrhythmic agents; who might have paralytic ileus; who might be hypersensitive to the active ingredient; and who have postoperative, mild, short-term, or intermittent pain.
This product must be used with extreme caution if patients are at risk of respiratory depression or are taking other central nervous system depressants (e.g., alcohol, benzodiazepines, other opioids, or illicit drugs) because of the possibility of additive effects. Caution should be used in patients at an increased risk of hypotension, in patients in circulatory shock, and in those with biliary tract disease, including acute pancreatitis. Butrans may worsen and obscure the signs of increased intracranial pressure. Patients should be monitored for decreased bowel motility and ileus.
Buprenorphine is also available as a sublingual tablet (Subutex, Reckitt Benckiser) and in other combinations.
Source: Purdue, July 1, 2010
Pfizer has announced that gemtuzumab ozogamicin (Mylotarg, Wyeth) will not be sold to new patients with relapsed acute myeloid leukemia (AML) in the U.S. The company is also voluntarily withdrawing the NDA for gemtuzumab beginning on October 15, 2010. Trial results have raised concerns about safety and have failed to show benefit.
Gemtuzumab was granted an accelerated approval in May 2000 for patients 60 years of age and older with recurrent AML who were not considered candidates for other chemotherapy; however, a clinical trial, begun in 2004, and post-marketing experience have not shown evidence of benefit in these patients.
After the initial approval, hepatotoxicity, veno-occlusive disease, hypersensitivity reactions, and pulmonary events were observed. A boxed warning was issued less than a year after the approval.
Current patients may complete their therapy after consulting with their physicians. All future use of gemtuzumab in the U.S. will require an investigational NDA to be submitted to the FDA.
Sources: FDA and Medscape, June 21, 2010
Cardiologists from Case Western Reserve University School of Medicine have noted an increased risk of cancer with the use of angiotensin-receptor blockers (ARBs). ARBs are used to control blood pressure (BP), to treat heart failure and diabetic kidney disease, and to reduce cardiovascular risk. Examples of ARBs include telmisartan (Micardis), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), valsartan (Diovan), losartan (Cozaar), and olmesartan (Benicar).
In the study, more than 60,000 patients receiving an ARB had a higher risk of a new cancer, compared with controls. The risk of new cancers was increased by 8% to 11% with ARBs, and the risk of lung cancer was increased by 25%. The research did not establish a link between ARBs and other malignancies such as breast cancer. The findings were robust but were not considered definitive.
Before this study, there were no major safety concerns with ARBs except in pregnancy, chronic kidney disease, and blocked kidney arteries. Previous studies of ARBs in animals had also been negative for cancer development.
Astellas Pharma and Boehringer Ingelheim, which jointly sell telmisartan in Japan, have emphasized its safety and have rebutted the cancer association. In five-year studies, no link to increased cancer risk was noted. The companies also say that the more recent study involved mainly a combination of telmisartan and ramipril rather than individual agents. The Case Western Reserve authors recommend that patients discuss the findings with their physicians, because ARBs are still effective for BP and heart failure.
Sources: Lancet Oncol online; Science Daily, June 15, 2010, www.sciencedaily.com; Bloomberg Business Week, June 14, 2010
The FDA has warned that the use of the quinine sulfate (Qualaquin, AR Scientific) to treat nighttime leg cramps has resulted in serious side effects. Qualaquin was approved in 2005 only to treat uncomplicated malaria.
A review of reports submitted to the FDA’s Adverse Event Reporting System between 2005 and 2008 found 38 cases of serious side effects associated with the use of quinine in the U.S., including low platelet levels, and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura. In some patients, these adverse effects resulted in permanent kidney impairment and hospitalization, and two patients died. Most patients reporting adverse effects were using the drug to prevent cramps or restless legs syndrome.
The FDA has requested that the manufacturer develop a risk-management plan and to issue a Dear Health Care Professional Letter to warn about the risk of hematological reactions.
Source: FDA, July 8, 2010
Patients who are prescribed thromboprophylaxis are more likely to adhere to a regimen of low-molecular-weight heparin (LMWH) than unfractionated heparin (UFH), say researchers from Brigham and Women’s Hospital and Harvard University. These results held true when UFH was given either twice or three times daily.
In the study, 95% of 250 patients took once-daily LMWH as prescribed, compared with 87% adherence among those who took UFH. Only 47% of patients who were given UFH received every scheduled dose, but 78% of those given LMWH received every scheduled dose.
Patient refusal was the most common reason for omitting a dose, regardless of whether UFH or LMWH was ordered. Patients sometimes refuse injection-based prophylaxis because of fear, anxiety, discomfort, or inconvenience or because they don’t understand their risk of venous thromboembolism and the purpose of preventive measures. A solution might lie in the availability of novel oral anticoagulant agents. Improved communication and education could encourage patients to participate in therapy, thereby improving adherence.
Source: Am J Med 2010;123:536–541
Postherpetic neuralgia (PHN) has long resisted easy treatment, and most patients end up taking a combination of anticonvulsants, antidepressants, and selective serotonin and serotonin–nor-epinephrine reuptake inhibitors (SSRIs and SNRIs), with complications resulting from multiple drugs without necessarily achieving relief.
Patients in pain may now have a simpler option: a high-concentration (8%) capsaicin transdermal patch (NGX-4010, NeurogesX). In phase 2 and 3 studies, the patch reduced pain in patients with both PHN and painful distal sensory polyneuropathy related to HIV infection. Relief was observed whether or not another neuropathic pain medication, such as opioids, was used.
To determine how long relief would last, researchers from Mount Sinai School of Medicine, in a NeurogesX-supported study, assessed repeated applications of the patch over one year in 54 patients with moderate-to-severe PHN and in 52 patients who had HIV-related neuropathy. Of those patients, 27 withdrew prematurely.
Almost half of the PHN patients had been in control groups in previous studies and had not received NGX-4010, whereas 62% of the HIV neuropathy patients had received three or four treatments. More patients with HIV-related neuropathy were receiving concomitant neuropathic pain treatment at the baseline examination. Patients received pre-treatment with a topical local anesthetic for 60 minutes, followed by either a 60-minute treatment (for PHN and neuropathy patients) or a 90-minute treatment (for neuropathy patients). Patients could receive up to three additional treatments at intervals of 12 weeks or more.
Although this was primarily a safety trial, pain relief was also assessed at weeks 12 and 48. At week 48 or at termination of the study, both groups reported improvement. At week 12, 65% of PHN patients and 74% of HIV-neuropathy patients were improved, and 33% in both groups felt very much improved.
Therapy was well tolerated, and nearly all patients completed at least 90% of treatments. Pain associated with treatment was self-limited and adequately controlled with cooling measures and/or rescue medications. Adverse events were similar in both groups, including application-site erythema and pain.
Source: J Pain Symptom Manage 2010; 39:1053–1064
It’s common for patients with diabetic peripheral neuropathy to also have cardiac neuropathy. The usual interventions target the reduced heart rate but may do nothing to help autonomic dysfunction. Gabapentin (Neurontin, Pfizer), however, may work on both fronts.
Researchers from Turkey gave 30 patients therapeutic doses of gabapentin, titrated as needed for neuropathic symptoms, up to a daily dose of 2,400 mg for three months. Patients were matched with 28 control participants who had no evidence of cardiovascular disease.
Gabapentin not only alleviated neuropathic symptoms but also improved cardiac autonomic functions in the diabetic patients; however, the improved heart rate variability values still were low compared with those in the control group. Most of the patients (83%) tolerated gabapentin well; the dose was easily titrated up to 2,400 mg/day. Five patients had dose-related, mild-to-moderate somnolence or dizziness requiring a dose adjustment.
Gabapentin was originally designed to mimic the effects of the neurotransmitter gamma-aminobutyric acid (GABA). This is the first study to test gabapentin’s possible effects on cardiac autonomic function. Although the researchers saw a good effect of gabapentin on heart rate variability parameters, the mechanism of the drug’s action remained unclear.
Source: J Diabetes Complications 2010; 24:229–233
Mometasone furoate nasal spray (Nasonex, Schering-Plough/Merck), an intranasal corticosteroid, has been effective in relieving nasal allergic rhinitis symptoms. According to work from the University of North Texas and the University of Cincinnati, the spray can also help tearing, burning, and itching eyes.
In a 15-day company-supported study, 429 patients with seasonal allergic rhinitis received once-daily mometasone 200 mcg or placebo. Patients reported improvement in all symptoms (31.3% for treatment, 21.7% for placebo). Mometasone reduced morning instantaneous symptom scores and reflective scores (about 12 hours later) for all symptoms except eye redness, which did improve but not significantly. Quality-of-life scores also showed clinically meaningful improvement. Total scores decreased by 41.5% with therapy and by 23.4% with placebo. Improvements lasted for 24 hours. Therapy was well tolerated. Treatment-emergent adverse events were low: 14.5% with therapy and 12% with placebo.
Source: J Allergy Clin Immunol 2010; 125:1247–1253
Older people, especially women, are often plagued by burning mouth syndrome, a chronic pain condition frequently accompanied by dry mouth and impaired taste. Effects can be minor or disruptive. Causes range from local nerve trauma, oral habits (e.g., teeth grinding and clenching), and salivar y gland dys function to menopausal dis orders, diabetes, and nutritional deficiencies. Repetitive microtrauma can lead to inflammation at the subclinical level.
Researchers from Seoul National University investigated the efficacy of oral habit control and the use of a topical glycerin-containing lubricant in 24 women and one man and habit control and topical dexamethasone (DXM) in another 27 women and two men.
Responding to a questionnaire, most patients had reported an oral burning sensation; some also reported stinging pain, itching, and numbness. Almost all of the patients complained of discomfort in the tongue area. More than half in both groups had more than one constant oral parafunctional habit, such as pressing the tongue against the teeth, clenching the jaw during the day, or grinding the teeth at night.
Both treatments significantly reduced burning and aching, and in both groups the effects of oral parafunctional habits on daily life were significantly decreased. However, no real difference between the two treatments was noted. Salivary flow rate did not affect outcomes, suggesting that the effects of the lubricant or DXM did not result from only a reduction in dry mouth symptoms. In fact, Visual Analogue Scale (VAS) scores of oral dryness were not significantly reduced in either group. The researchers concluded that a topical lubricant, combined with habit control, was an effective first step for patients with burning mouth syndrome. Neuropathy agents such as selective serotonin reuptake inhibitors (SSRIs) and clonazepam (Klonopin, Roche/Genentech) can be reserved for patients who don’t respond to this simple initial treatment.
Source: Arch Gerontol Geriatr 2010; 51:95–99
Older men receiving a testosterone skin gel (Testim, Auxilium) have experienced a higher incidence of adverse cardiovascular events than men receiving a placebo.
The double-blind, placebo-controlled, randomized trial—Testosterone in Older Men (TOM)—had been supported by a grant at Boston Medical Center from the National Institute on Aging. Researchers wanted to determine the effects of six months of gel treatment on strength and ability to walk and climb stairs in 209 older men with low testosterone levels and mobility limitations. Testosterone supplementation is known to increase muscle mass and strength in healthy older men.
Therapy was stopped on December 31, 2009, after 23 of the treated 106 men (22%) experienced adverse cardiovascular events, compared with five of the 103 men (5%) who received placebo. Events included heart attacks, arrhythmias, and elevated BP; one patient died after a suspected heart attack.
In the study, the gel was applied to the skin each day. The participants (average age, 74) had high rates of chronic diseases, such as diabetes and cardiovascular disease.
No new participants will be enrolled. The study team plans to continue to monitor the health of all participants for at least another year after stopping testosterone use to further evaluate effects of the therapy. The trial had excluded men with severely low testosterone levels, thus limiting the ability to make inferences about safety in this population. Testosterone doses and serum levels in this trial might have been higher than those usually used in clinical practice.
Source: N Engl J Med 2010;363:109–122; National Institutes of Health; Bloomberg News, June 30, 2010
There is growing evidence that fish oil supplements might prevent chronic disease. Researchers from Seattle asked 35,016 postmenopausal women without a history of breast cancer to complete a 24-page questionnaire about their use of non-vitamin, non-mineral specialty supplements in the Vitamins and Lifestyle (VITAL) cohort study.
After six years of follow-up, 880 cases of breast cancer were identified. The regular use of fish oil supplements, which contain high levels of the omega-3 fatty acids EPA and DHA, was linked with a 32% reduced risk of invasive ductal breast cancer, the most common type. Other specialty supplements were not associated with breast cancer risk.
This is the first research to show a link between fish oil and a reduction in breast cancer; however, studies of dietary intake of fish or omega-3 fatty acids have not been consistent. The amount of omega-3 fatty acids in fish oil supplements is higher than most people might typically get from their diet. The lead study author cautioned against gleaning any recommendations from one study.
Another trial (also called VITAL) is now enrolling patients to assess the effect of fish oil and vitamin D on cancer, heart disease, and stroke.
Sources: Cancer Epidemiol Biomarkers Prev, 2010;19(7):1696–1708; www.vitalstudy.org
Aggressive drug treatment to lower blood sugar, blood pressure (BP), and cholesterol in diabetic patients might not prevent heart disease and strokes, but it may help prevent diabetic eye disease, nerve damage, and kidney disease.
The five-year study, ACCORD (Action to Control Cardiovascular Risk in Diabetes), had been halted temporarily in February 2008 because there were 20% more deaths among diabetic patients with heart problems who received intensive treatment to lower glucose levels compared with patients who were treated more conservatively.
Giving more drugs and adding a fibrate to statin cholesterol drugs did little to prevent heart problems, but the strategy did help to prevent diabetic retinopathy, a chief cause of vision loss. Because intensively lowering glucose levels in some patients can increase the risk of death from heart problems or can cause hypoglycemia, doctors should treat each patient individually.
In ACCORD, researchers had sought to prove that reducing glucose levels to near-normal levels in diabetic patients would prevent heart complications; however, there was no difference in the risk of heart disease when glucose was lowered to a hemoglobin A1c level of below 6% (a normal level), compared with standard goals of 7% to 7.9%. Patients receiving intensive care, however, did have less protein in the urine (a sign of kidney disease) and had sharper vision and better nerve function than those who received standard care.
Diabetic retinopathy developed more slowly with aggressive therapy with a fibrate and a statin than with standard treatment. The trial is the first to show that adding a fibrate to a statin can reduce the progression of diabetic eye disease.
Sources: Lancet online, June 29, 2010; Reuters
An expensive protein therapy used for alpha1-antitrypsin deficiency, a hereditary disorder, has not shown any clinical benefit, say Cochrane researchers. Their review concludes that because of the lack of evidence for its benefits and the possible adverse effects, the treatment should not be recommended.
This disorder, which causes chronic lung disease, affects fewer than one in 1,600 people. Patients have low levels of the protein alpha1-antitrypsin, which protects the tissue of the lungs from destruction by the body’s white blood cells. At a relatively young age, this deficiency can result in symptoms of emphysema. The aim of therapy is to replace the protective protein in order to limit damage to lungs and, ultimately, to prevent early death. The protein is extracted from blood donated by healthy volunteers.
The researchers reviewed two trials involving 140 patients. In one trial, the patients received the protein or a placebo every four weeks for three years. In the other trial, the protein or a placebo was given weekly for a minimum of two years.
There was no difference between the treatment and control groups in terms of exacerbations of lung disease or quality of life, and no evidence of a clinically important effect on lung function was noted. The results actually suggested modest harm or, at best, no effect.
From this evidence, the researchers say that the treatment, which costs up to $150,000 a year in the U.S., cannot be recommended. Neither trial reported mortality data, and adverse events were not well reported. In previous studies, a small proportion of patients experienced allergic reactions and breathing difficulties following treatment. The researchers concluded that the American Thoracic Society and European Respiratory Society, which promote alpha1-antitrypsin replacement, are misguided.
Source: The Cochrane Library, July 7, 2010
A vaginal gel containing tenofovir (Viread, Gilead) is the first agent to show protection against the AIDS virus, reducing the incidence of infection in women by more than 50% when used consistently.
The microbicide gel—known as PRO 2000 (Indevus), has been found to be safe and approximately 30% effective (33% effectiveness would have been considered statistically significant). This is the first human study to suggest that a microbicide might prevent male-to-female sexual transmission of the virus.
Currently, women make up half of all people worldwide living with HIV. In sub-Saharan Africa, they represent nearly 60% of adults living with HIV. In several southern African countries, young women are at least three times more likely to be HIV-positive than young men. In most cases, women become infected with HIV through sexual intercourse with an infected male partner. Because most new HIV infections in sub-Saharan Africa affect women, there is a sense of urgency surrounding the development of HIV-prevention tools for this group of patients.
Six potential microbicides have been tested in 11 large trials over the past 15 years, but the current trial (CAPRISA 004) is the first to use an antiretroviral drug. Most of the products tested previously as microbicides were either sulfated polysaccharides, which stop the virus from entering cells, or agents that kill either the virus or cells that carry it.
The study, sponsored by the Centre for the AIDS Programme of Research in South Africa (CAPRISA), involved almost 90 heterosexual women in South Africa. The women were between 18 and 40 years of age and were HIV-negative, sexually active, and at high risk of HIV infection. Compared with a placebo gel, the tenofovir gel cut HIV infection in the group by 39% overall, and by 54% in particpants who used the gel most consistently. The gel also reduced herpes simplex virus 2 (HSV-2) infections by 51%. This is important, because the risk of HIV infection doubles for women with HSV-2 infection.
This success represents only a first step. The trial’s design had been criticized, particularly the dosage schedule: women had to apply the gel less than 12 hours before intercourse and again within 12 hours after intercourse rather than daily. The researchers hope to develop a product that will be easier to use.
More safety data are needed. The product is in limited supply and probably won’t be available to women in South Africa or elsewhere for at least a year or two. However, the South African Medicines Control Council could decide to start providing it sooner to women with the most need.
Sources: Science online, July 19, 2010; Nature News, Associated Press, July 20, 2010; www.caprisa.org
Pfizer has announced the creation of a new research unit to study diseases that affect fewer than 200,000 patients. In February, GlaxoSmithKline also unveiled plans for a stand-alone rare-diseases unit.
Pfizer earlier indicated that it would collaborate with Israel-based Protalix Biotherapeutics to develop taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase, a potential therapy for Gaucher disease. Pfizer and a Swiss research group also agreed to work on advances in human African trypanosomiasis, visceral leishmaniasis, and Chagas disease, which afflict populations in the developing world.
Fewer than 10% of orphan diseases have therapies that directly address the underlying problem.
Sources: DataMonitor, June 16, 2010; Pharma Letter, June 17, 2010
The first rapid blood test for detecting antibodies to the hepatitis C virus (HCV) has been approved for individuals 15 years of age and older. The OraQuick HCV Rapid Antibody Test (OraSure) is for those who have signs or symptoms of hepatitis. OraQuick is a test strip, and instruments are not required for diagnosis. It takes about 20 minutes to obtain results. The test is not approved for HCV screening of the general population.
Approximately 3.2 million people in the U.S. have chronic HCV infection.
Source: FDA, June 25, 2010
The FDA has approved VisionCare’s Implantable Miniature Telescope to improve sight in some patients with end-stage, age-related macular degeneration (AMD). The device replaces the natural lens and provides an image that has been magnified more than two times.
Damage to the macula results in a loss of vision in the center of the visual field, making it difficult or impossible to recognize faces or to read. The device magnifies and projects images onto a healthy portion of the retina. It is implanted in only one eye; the non-implanted eye is used for peripheral vision.
Patients must be 75 years of age or older with stable, severe-to-profound vision impairment caused by blind spots associated with end-stage AMD. Patients agree to undergo training with an external telescope before surgery to determine whether their sight improves adequately, and they must participate in a training program after surgery.
In a clinical study, 90% of patients achieved some visual acuity, and 75% improved from severe or profound vision impairment to moderate impairment.
Because the device is large, implantation can lead to loss of corneal endothelial cells. Significant losses may lead to the need for corneal transplant. Concern about corneal damage delayed FDA approval for several years. VisionCare Ophthalmic Technologies is required to conduct two post-approval studies.
Sources: FDA, July 6, 2010; Pharma Letter, June 17, 2010
Name: Genesys Hydro Therm-Ablator System
Manufacturer: Boston Scientific Corp., Natick, Mass.
FDA Approval Date: May 18, 2010
Purpose: The system is indicated for ablation of the endometrial lining of the uterus in premenopausal women with abnormally heavy or prolonged menstrual bleeding. The device was approved in January 2010 for marketing in Europe.
Description: A small probe with a tiny telescope is inserted into the uterus for visualization of the uterine cavity while room-temperature saline solution is circulated through the uterine cavity. The fluid is gradually heated to treat the uterine lining. When the treatment phase is completed, a cool saline solution replaces the heated fluid and the instrument is removed. Patients generally go home the same day. Cramping may occur, but it usually resolves by evening. Vaginal discharge is typically experienced for a few days but may last as long as a few weeks.
Benefit: Approximately 10 million women in the U.S. have menorrhagia. Endometrial ablation may be an alternative to hysterectomy for premenopausal women with menorrhagia resulting from benign causes for whom childbearing has been completed. Several upgrades have been incorporated to improve operating performance while delivering the same therapy of the previous-generation system. Compared with the company’s previous endometrial ablation system, the new product features a smaller and lighter console, simplified setup requirements, and an enhanced graphic user interface that offers step-by-step guidance during the procedure.
Name: COBAS AmpliPrep/COBAS TaqMan HIV-1 Viral Load Test
Manufacturer: Roche, Pleasanton, Calif.
FDA Approval Date: May 22, 2010
Purpose: This in vitro nucleic acid amplification test is used to quantify the amount of HIV-1 RNA in a patient’s plasma. The test is used along with clinical presentation and other laboratory markers of disease progression. The clinician can assess a patient’s prognosis by measuring baseline HIV-1 RNA concentrations and can monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.
Description: Specimen preparation is automated. The test consists of specimen preparation to isolate HIV-1 RNA, reverse transcription of the target RNA to generate complementary DNA, and simultaneous polymerase chain reaction amplification of target complementary DNA and detection of cleaved dual-labeled oligonucleotide probe specific to the target.
Benefit: Sensitivity for detecting current and emerging genomic variants of HIV is excellent.
Precaution: The test is not designed to screen for the presence of HIV-1 in blood or blood products or to confirm the presence of HIV-1 infection.