Biogen announces FDA, EMA accepted applications for higher dose of nusinersen

Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, and the European Medicines Agency, EMA, has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy, SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen, SPINRAZA.