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Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023 CAMBRIDGE, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Biogen Inc.
About this update from Biogen Inc.
[{"type":"text","content":"The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023 CAMBRIDGE, Mass., 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 investigational treatment for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (PDUFA) goal date is April 25, 2023. As part of the ongoing review, Biogen submitted responses to information requests by the FDA which the FDA considered a Major Amendment to the application that will require additional time for review. “We are committed to providing any details the agency needs to complete the review of tofersen,” said Priya Singhal, M.D., M.P.H., Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. “As the review continues, Biogen will maintain the early access program for tofersen.” The FDA accepted the tofersen NDA in July 2022 under the accelerated pathway and granted priority review. About TofersenTofersen 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. In addition to the ongoing open label extension of VALOR, tofersen is being studied in the Phase 3 ATLAS study designed to evaluate whether tofersen can delay clinical onset when initiated in presymptomatic individuals with a SOD1 genetic mutation and biomarker evidence of disease activity. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement. About Amyotrophic Lateral Sclerosis and SOD1-ALSAmyotrophic 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. Average life expectancy for people with ALS is three to five years from time of symptom onset.1 Multiple genes have been implicated in ALS. Genetic test...