Biogen (BIIB) Announces FDA Grants Accelerated Approval for QALSODY for SOD1-ALS

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FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS

April 25, 2023 3:04 PM EDT

FDA granted accelerated approval of QALSODY based on a reduction of neurofilament, a marker of neurodegeneration1Superoxide dismutase 1 (SOD1)-amyotrophic lateral sclerosis (ALS) is a devastating, uniformly fatal,2 and ultra-rare genetic form of ALS3-4 with approximately 330 people in the U.S. living with the disease5

CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)... More