FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Endorses Spinraza as Initial Treatment for Spinal Muscular Atrophy

June 7, 2017
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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.

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