New Drug Approvals Spike

FDA gave the green light to 39 new drugs in 2012, up from 30 in 2011 and the highest number of drug approvals since 1996. In December alone the agency approved eight new products. Among them was Eliquis, comarketed by Bristol-Myers Squibb and Pfizer to lower the risk of stroke in people with atrial fibrillation. Aegerion Pharmaceuticals’ Juxtapid was approved to lower cholesterol in people with a rare genetic disorder called homozygous familial hypercholesterolemia, which renders them unable to get rid of “bad” cholesterol. NPS Pharmaceuticals’ Gattex was okayed to improve absorption of fluid and nutrients in people with short bowel syndrome, which occurs after part of the small or large intestine is removed. Johnson & Johnson’s Sirturo was the first drug approved to treat multi-drug-resistant tuberculosis. And at the last hour, FDA approved Salix Pharmaceuticals’ Fulyzaq, the first drug to treat diarrhea in HIV/AIDS patients taking antiretroviral therapy. Derived from Croton lechleri plants, Fulyzaq is one of only two botanical prescription drugs ever to win the agency’s nod.