ARTICLE | Company News

FDA, EMA accept submissions for nusinersen for SMA

October 28, 2016 7:00 AM UTC

Biogen Inc. (NASDAQ:BIIB) said FDA accepted and granted Priority Review to an NDA for nusinersen to treat spinal muscular atrophy (SMA). Concurrently, EMA accepted an MAA for the compound in the indication.

EMA's CHMP has granted the product accelerated assessment. Biogen spokesperson Todd Cooper declined to provide a PDUFA date for the NDA. ...