Biogen Says FDA Granted Granted Breakthrough Therapy Designation for Spinal Muscular Atrophy Drug

MT Newswires Live06-04 19:53

Biogen (BIIB) said Thursday that the US Food and Drug Administration has granted breakthrough therapy designation for Salanersen to treat spinal muscular atrophy, a rare, genetic and neuromuscular disease.

The designation is intended to expedite the development and review of drugs that treat a serious condition.

The biotech firm said preliminary clinical evidence suggests the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

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