Biogen Inc.’s (BIIB) Tofersen, an investigational product for the treatment of superoxide dismutase 1 amyotrophic lateral sclerosis, awaits the final FDA decision on April 25, 2023.Tofersen was licensed by Biogen from Ionis under a collaboration agreement signed in 2018.Amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, is a fatal neurological condition characterized by the progressive loss of motor neurons in the brain and spinal cord, which control voluntary muscle movement. Multiple genes have been implicated in ALS. About 2% of the estimated 168,000 individuals worldwide who have ALS are affected by mutations in the superoxide dismutase 1 (SOD1) gene.Tofersen works by binding to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce synthesis of SOD1 protein production.Amylyx Pharmaceuticals' Relyvrio, Mitsubishi Tanabe Pharma's Radicava, Sanofi's Rilutek, ITF Pharma's Tiglutik, Aquestive Therapeutics' Exservan and Avanir Pharmaceuticals' Nuedexta are the approved drugs for ALS. However, there are no genetically targeted treatment options for ALS yet.Although the FDA panel had given mixed vote related to approval of Tofersen, a consensus was reached that the benefit-risk profile was favorable based on the review of the totality of data to recommend its approval.BIIB closed Thursday’s trading at $275.13, up 0.41%.