Biogen Idec’s Plegridy gains US approval for multiple sclerosis

The US Food and Drug Administration has approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS), the company announced on Friday, when its share price edged 1.6% higher to $342.47 in anticipation of the approval, news of which came after markets closed. The stock is up 22% so far this year.

Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.

The US approval comes after the  FDA earlier this year extended the initial Prescription Drug User Fee Act (PDUFA) date for its review by three months, but did not request further data. Just last month,  the European Commission approved Plegridy for the treatment of adults with relapsing-remitting multiple sclerosis.