The European Commission granted marketing authorization to Biogen’s Spinraza for the treatment of 5q spinal muscular atrophy.

The approval is based on results from two studies, including end-of-study data from infantile-onset SMA and an interim analysis of later-onset SMA. The drug is administered by injection directly to the cerebrospinal fluid around the spinal cord.

Spinraza was approved by the FDA in December 2016.