Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen

發(fā)布時(shí)間： 2022-10-18 閱讀：433次

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Oct. 17, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for tofersen by three months.

Tofersen is an antisense drug being evaluated for the potential treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce synthesis of SOD1 protein production.

Amyotrophic lateral sclerosis (ALS) is a rare, progressive and fatal neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord that are responsible for controlling voluntary muscle movement. People with ALS experience muscle weakness and atrophy, causing them to lose independence as they steadily lose the ability to move, speak, eat, and eventually breathe.

The FDA accepted the tofersen NDA in July 2022 under the accelerated pathway and granted priority review, the new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023