Just in time for flu season, the FDA has approved the first generic oseltamivir (Tamiflu) to treat and prevent influenza. The drug is indicated for patients ≥ 2 weeks of age who have suffered from flu symptoms for no more than 48 hours and for prevention of the flu in patients ≥ 1 year of age. Natco Pharma and its U.S. partner, Alvogen, have the first generic approval and will be the only generic supplier for six months under a patent agreement with Roche Pharmaceuticals, the manufacturer of Tamiflu.
AstraZeneca has lost a last-ditch effort to protect its blockbuster statin rosuvastatin (Crestor) from generic competition. The company argued before a federal court that the drug had recently been approved under the Orphan Drug Act to treat children with homozygous familial hypercholesterolemia, a rare condition. AstraZeneca lost the case and was criticized for attempted abuse of the Orphan Drug Act, according to The New York Times. Subsequently, the FDA approved several more generic versions of rosuvastatin in early August. The drug’s first generic copy was approved in May.
The FDA has approved the fifth GLP-1 agonist to treat type 2 diabetes. Lixisenatide is a once-daily injection used to improve glycemic control along with diet and exercise in type 2 diabetics. The drug previously was approved in Europe in 2013. It is not indicated for type 1 diabetes or diabetic ketoacidosis. The approval was based on 10 clinical trials consisting of 5,400 patients presenting with type 2 diabetes in which the drug was evaluated as a standalone therapy and in combination with metformin, sulfonylureas, pioglitazone, and basal insulin. Lixisenatide improved A1c levels in these trials. In 6,000 patients at risk for cardiovascular disease, lixisenatide did not increase the risk of adverse events.
The FDA has approved lifitegrast ophthalmic solution for the treatment of dry eye disease. The drug is the first of a new class of lymphocyte function-associated antigen 1(LFA-1) antagonists. Safety and efficacy was shown in four studies of more than 1,000 patients (76% female) age 19-97 years. Patients were randomized to lifitegrast or placebo twice a day for 12 weeks. Lifitegrast resulted in more improvements in both the signs and the symptoms of eye dryness than the groups treated with placebo. Lifitegrast ophthalmic solution is marketed as Xiidra. It is expected to be priced at $426 for a 30-day supply.
The FDA has approved adapalene gel 0.1% (Differin Gel) for OTC use for the treatment of acne in those ≥ 12 years of age. It represents the first retinoid to be available OTC and is the first new active ingredient for acne available OTC in nearly 30 years. The drug was originally approved in 1996. Five postmarking trials have proven safety and efficacy since 1996, also showing that consumers can understand the OTC labeling and use the product appropriately. Adapalene gel 0.1% OTC will be marketed as Differin Gel 0.1%.
In this section: FDA approves generic influenza treatment; major pharma loses statin battle; FDA gives thumbs up to agonist to treat type 2 diabetes; agency green lights dry eye disease solution; and approves over-the-counter acne treatment.
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