# FDA Approves Biogen's SPINRAZA for Spinal Muscular Atrophy, Opening Rare Disease Market Opportunity Biogen Inc. received FDA approval for SPINRAZA (nusinersen), an intrathecal treatment for spinal muscular atrophy, positioning the company as a first-mover in a previously untreated rare disease market with significant commercial potential. The December 2016 approval is expected to generate substantial revenue for Biogen given the orphan drug designation and the disease's high unmet medical need among pediatric and adult patients.