Xconomy took Christmas week off, but the FDA didn’t—the agency issued a flurry of new drug approvals in the last two weeks of the year, bringing its total number of approvals for 2012 to 39, the highest yearly total in 16 years. Some of those last minute approvals benefited East Coast companies. (Drumroll, please):
—- The big one of the FDA actions was its approval on Dec. 28 of the blood thinner apixaban (Eliquis), jointly developed by Pfizer (NYSE: [[ticker:PFE]]) and Bristol-Myers Squibb (NYSE: [[ticker:BMY]]), both in New York. Apixaban was cleared to reduce the risk of stroke in patients with atrial fibrillation, the most common type of irregular heartbeat, and the target patient population is about 5.8 million people in the U.S. alone. Bristol-Myers and Pfizer will be up against rivaroxaban (Xarelto), approved in 2011 and marketed by Johnson & Johnson (NYSE: [[ticker:JNJ]]) and Bayer, and Boehringer Ingelheim’s dabigatran (Pradaxa), which hit the market in 2010. But given that the global market for blood thinners is an estimated $15 billion annually, apixaban is expected to be a blockbuster even if it shares the wealth.
—On the last day of 2012 the FDA okayed the first drug designed to treat multi-drug resistant tuberculosis, Johnson & Johnson’s bedaquiline (Sirturo). Made by J&J’s Janssen Therapeutics division in Titusville, NJ, bedaquiline is meant for patients who have failed to respond to all other treatments, a growing problem around the globe.
—-Meanwhile, Alkermes (NASDAQ: [[ticker:ALKS]]) kicked off 2013 with the news on Thursday that it is planning a Phase II clinical trial of a new schizophrenia treatment that combines Eli Lilly’s olanzapine (Zyprexa) with its ALKS33 compound. Alkermes, headquartered in Ireland but with a large facility in Waltham, MA, is hoping its combination drug will avoid the weight-gain often associated with olanzapine, which went off patent in 2011.
—The new year brought some sad news for patients suffering from amyotrophic lateral sclerosis (ALS). Biogen Idec (NASDAQ: [[ticker:BIIB]]) of Weston, MA, announced that its once-promising drug for the disease definitively failed a Phase III clinical trial, and it is halting further development. That means there continues to be no cure, no long term therapy, and no known cause for this deadly neurodegenerative disorder that is also known as Lou Gehrig’s disease.
