EU Endorses Spinraza as Initial Treatment for Spinal Muscular Atrophy
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.