Posted by Michael Wonder on 23 Jan 2025
FDA and EMA accept applications for higher dose regimen of nusinersen in spinal muscular atrophy
23 January 2025 - Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of spinal muscular atrophy.
Biogen announced that the US FDA has accepted the company’s supplemental new drug application and the EMA has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy.
