Tuesday, February 28, 2012

Biogen sends oral MS drug to FDA

By Julie M. Donnelly

Biogen Idec (Nasdaq: BIIB) has sent its potential oral therapy for multiple sclerosis, BG-12, to the U.S. Food and Drug Administration for review.

The Weston, Mass.-based company is hoping that the regulatory body will grant the drug candidate an accelerated, six-month approval process, rather than the standard, 10-month review. If approved, BG-12 would be the second oral MS therapy on the market.

Gilenya, marketed by Swiss drug maker Novartis AG (NYSE: NVS), was approved in 2010, but some analysts believe Biogen’s drug may be more potent.“While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways,” said Douglas E. Williams, Ph.D., Biogen’s executive vice president of research and development, said in a statement. “Based on the robust clinical efficacy and safety data seen in our Phase 3 studies, we believe BG-12 has the potential to become an important oral treatment option for MS patients.”

Biogen already has three FDA-approved therapies for multiple sclerosis, including Avonex, Tysabri, and the recently-approved Fampyra, which aids MS patients with walking.Biogen also said Tuesday that the FDA has approved a new form of the injectable drug Avonex, called the Avonex Pen, which includes a smaller needle. Patients administer the drug themselves, rather than traveling to a health care facility, and Biogen says the new pen makes the process easier and less painful.Biogen plans to submit BG-12 to European regulators in the coming days.