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

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.