Biogen hits an FDA speed bump with its next-gen MS drug

The FDA said it needs three more months to consider Biogen Idec's ($BIIB) Plegridy, an injectable multiple sclerosis treatment, delaying an expected midyear launch for the company's latest entrant in its blockbuster MS franchise. The agency isn't demanding additional studies, Biogen said, and analysts aren't sweating the delay, in large part because of reduced expectations for injected MS treatments. Thanks to Biogen's stratospherically successful oral treatment, Tecfidera, interferon-based treatments like Plegridy are widely expected to decline in popularity. Plegridy is a pegylated formulation of interferon beta-1a that treats relapsing MS with injections either a once or twice a month, designed to usurp more frequent injected therapies like Biogen's own Avonex. More