FDA actions

FDA actions

The FDA has approved the second new weight-loss medication within a month. The new product combines phentermine along with topiramate in an extended-release product. Phentermine has been marketed since 1959 and was part of the infamous "fen-phen" combination that was popular in the 1990s (fenfluramine was eventually banned due to cardiac valvulopathy in 1997). Topiramate is currently marketed as an anticonvulsant and for migraine prophylaxis as Topamax. The combination was rejected by the FDA in 2010 due to safety concerns, but Vivus Pharmaceuticals submitted additional data to the agency and recently won approval in July. In the process, the company changed the brand name from Qnexa to Qsymia. Similar to the recently approved lorcaserin (Belviq), phentermine/topiramate is approved as an addition to a reduced-calorie diet and exercise for weight management in adults with a BMI of 30 or greater, or with a BMI of 27 or greater with at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia. In two placebo-controlled trials, 3700 obese and overweight patients lost an average of 6.7-8.9% of their body weight, depending on the recommended or higher dose therapy (slightly better results than those seen with lorcaserin). Patients who have not lost at least 3% of their body weight by week 12 should discontinue the drug. Because of continued safety concerns, the drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a medication guide, prescriber training, and pharmacy certification. The drug cannot be used during pregnancy or in patients with recent stroke or heart disease, and patients should have their heart rates monitored during therapy. Vivus will market Qsymia immediately, but will be required to conduct 10 postmarketing studies to assess safety.

The FDA has approved aclidinium bromide, a dry powder inhaler for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Aclidinium is a long-acting antimuscarinic agent that works primarily on the M3 receptor causing sustained bronchodilation. The approval was based on three studies of nearly 1300 patients with COPD. The drug may cause anticholinergic side effects, including worsening narrowing-angle glaucoma and urinary retention. It should not be used as a rescue inhaler and is not recommended for those 18 years of age or younger. It is dosed twice a day. Aclidinium inhaler is the second anticholinergic inhaler to be approved after tiotropium (Spiriva), which was approved in 2004. Aclidinium will be distributed by Forest Laboratories and will be marketed as Tudorza Pressair.

The FDA has approved mirabegron to treat adults with overactive bladder. The drug is a novel, once-daily beta-3 adrenergic agonist that works by enhancing storage function and relaxing the urinary bladder, a unique effect and distinct from currently marketed antimuscarinics that inhibit bladder contraction. The once-a-day medication will be available in 25 mg pills. The dose can be increased to 50 mg after 2 months if needed. The approval was based on three placebo-controlled trials that showed statistically significant improvement in incontinence episodes and number of urinations per 24 hours. The most common adverse effects were hypertension, nasopharyngitis, urinary tract infection, and headache. Mirabegron will be marketed by Astellas Pharma as Myrbetriq.

The FDA has approved a new colon cleansing agent for colonoscopy prep. The new prep is sodium picosulfate, magnesium oxide, and citric acid in powder form that is dissolved in water and taken in two doses the night before and the morning of the procedure. It may also be taken the afternoon and the evening before the procedure (Day-Before regimen). The safety and efficacy of the new agent was studied in two studies of about 1200 patients undergoing colonoscopy in which standard PEG plus electrolytes was used as a comparator, and the new prep was found to be at least as effective as the standard prep. Ferring Pharmaceuticals will market the new two-dose prep as Prepopik.

The FDA has approved icosapent ethyl, a new fish oil preparation for the treatment of hypertriglyceridemia. It is approved as an adjunct to diet to treat patients with triglyceride levels greater than 500 mg/dL. The drug contains ultra purified ethyl EPA, an omega-3 fatty acid. The new product follows GlaxoSmithKline's Lovaza, another fish oil that is currently marketed for the same indication and generates more than $1 billion in annual sales. The new product is manufactured by Amarin Corporation and will be marketed as Vascepa. Fish oils are effective at lowering triglycerides but evidence is lacking that they are effective for secondary prevention of cardiovascular disease (Arch Intern Med 2012;172:686-694).

An FDA advisory committee has recommended an new indication for Genentech's ranibizumab (Lucentis) for the treatment of diabetic macular edema, an indication for which there is currently no approved therapy. The drug is approved to treat neovascular age-related macular degeneration and macular edema following retinal vein occlusion. Diabetic macular edema is commonly treated with laser therapy, a procedure that has the potential side effect of some vision loss. The FDA generally follows its advisory committee's recommendations and should make a final recommendation later this year.