On September 16, 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Accelerated Assessment for the nusinersen Marketing Authorization Application (MAA) for the treatment of European patients with spinal muscular atrophy (SMA).
Accelerated Assessment reduces the timeframe for the CHMP to review a MAA. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and a therapeutic innovation. The accelerated review procedure may decrease the standard 210-day time limit for the CHMP to grant an opinion by approximately two months. Accelerated Assessment also requires the sponsor to respond in a shorter timeframe (30 days) to questions from the CHMP (the “clock-stop” periods). This is compared to the normal response time of 3-4 months. Programs granted Accelerated Assessment can be switched back to the standard assessment time frame at any time.