1 June 2017 - Robust data from phase 3 studies demonstrated positive impact on motor milestone achievement; increased survival in infants with spinal muscular atrophy.

The European Commission has granted a marketing authorisation for Sprinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA), Biogen announced today. 

5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases. Spinraza is the first approved treatment in the European Union for SMA, a leading genetic cause of death in infants that is marked by progressive, debilitating muscle weakness. 

Spinraza was reviewed under the EMA accelerated assessment program, intended to expedite access to patients with unmet medical needs.

Read Biogen press release