Biogen Idec Inc. expects federal regulators to rule by March about relaunching multiple sclerosis drug Tysabri in the marketplace. MarketWatch reported that the Cambridge, Mass.-based company (Nasdaq: BIIB) expects the ruling to focus on whether to approve a new warning label stating that the drug has been linked to a rare but deadly brain disease known as PML. Tysabri, approved in late 2004, was voluntarily pulled from the market in February over safety concerns.
Three Tysabri MS patients were reported to have come down with PML and two subsequently died. Biogen and Irish drug development partner Elan Corp. (NYSE: ELN) have since conducted a safety review. They submitted a new approval application last fall that would allow Tysabri to be marketed with the revised warning label.
