Dexpramipexole: Development discontinued

Biogen Idec discontinued development of dexpramipexole after top-line data from the double-blind, international Phase III EMPOWER trial in 943 ALS patients showed that twice-daily 150 mg dexpramipexole for up to 18 months missed the primary endpoint of improving function and survival as measured by the change in CAFS scores from baseline to 12 months vs. placebo. The company also said dexpramipexole failed to show efficacy in the individual function and survival components of the CAFS, on secondary endpoints and in analyses of multiple subpopulations. Biogen Idec has exclusive, worldwide rights from Knopp to develop and commercialize dexpramipexole under a 2010 deal (see BioCentury, Aug. 23, 2010). Biogen Idec, which made the announcement on Jan. 3, declined to comment on whether it would return rights to the product. Dexpramipexole has Orphan Drug designation in the U.S. and Europe and Fast Track designation in the U.S. to treat ALS. ...