ARTICLE | Clinical News
Nusinersen regulatory update
October 3, 2016 7:00 AM UTC
Biogen completed submission of a rolling NDA to FDA for nusinersen to treat spinal muscular atrophy (SMA). The company will seek Priority Review for the application. Biogen also said it plans to submit an MAA to EMA for nusinersen in “the coming weeks” and regulatory submissions in other countries in “the coming months.” EMA’s CHMP granted the product accelerated assessment. ...