Company news: Bristol-Myers Squibb, Corcept Therapeutics, Vivus, Orexigen and Arena
The FDA is giving weight-loss drug, Qnexa, from Vivus, a second look, two years after rejecting the drug because of concerns that the side effects were too great. Memory loss, birth defects and cardiovascular problems were among the problems that kept the drug off pharmacy shelves in 2010. The drug is comprised of appetite suppressant phentermine and anticonvulsive topimarate. Phentermine was part of diet pill Phen-fen which was pulled from the market in 1997 over heart damage. Topimarate, initially developed by Johnson & Johnson, is used to treat migraines. Qnexa would be the first approved prescription weight loss drug in over a decade. Orexigen and Arena are also seeking approval for obesity treatments. According to the Centers for Disease Control data more than one-third of US adults are obese, and the number of states with an obesity index of 30% or more is rising. Yet these numbers may not be enough to outweigh concerns. According to TheStreet the panel is stacked against the approval. Among the reasons: 12 of the experts were part of the last rejection committee.
The FDA has greenlighted the first-ever treatment for endogenous Cushing's Syndrome in the US. The once-a-day drug, Korlym from Corcept Therapeutics, has an uphill battle despite its exclusivity: it is an active ingredient in the abortion pill RU-486. The drugmaker conceded in its September quarterly report that this affiliation may make the small patient group even smaller, reported Bloomberg. Korlym is approved for patients with endogenous Cushing's syndrome, which means the glands are producing far too much cortisol, which is often caused by tumors, as opposed to exogenous Cushing's Syndrome, caused by an external trigger such as corticosteroids. Competitor Novartis tried to enter the this market last year, with EU-approved injection drug Signifor, before quality issues caused the Swiss giant to pull the application from the US. Corcept expects its drug to be available to patients by May 1.