US FDA calls for further data on Biogen Idec’s Eloctate

13 November 2013

Swedish Orphan Biovitrum (STO: SOBI) has announced that its partner, US biotech major Biogen Idec (Nasdaq: BIIB), has received a request from the US Food and Drug Administration for additional information relating to their hemophilia A drug candidate Eloctate (recombinant factor VIII Fc fusion protein).

Biogen Idec revealed at the Credit Suisse Global Healthcare Conference in Phoenix, that the FDA is seeking process validation of certain steps in the manufacturing process for Eloctate. As a result, Biogen Idec expects a Prescription Drug User Fee Act (PDUFA) extension for the drug and the company is now planning for a mid-2014 commercial launch in the USA based on on-going discussions with the FDA. The delay is equal to about 90 day later than originally anticipated.

No impact seen on European approval timelines

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