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Ionis (IONS) issued the following statement about the FDA advisory committee meeting on tofersen: "On Jan. 23, the Federal Register published a notice that the U.S. Food and Drug Administration will convene a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review data supporting the New Drug Application for tofersen, an investigational medicine for the treatment of superoxide dismutase 1 amyotrophic lateral sclerosis - SOD1-ALS. The advisory committee meeting is scheduled for March 22, 2023. SOD1-ALS is an ultra-rare genetic form of ALS that affects approximately 330 people in the U.S.1 It is progressive, leads to the loss of everyday functions and is uniformly fatal. The NDA for tofersen has a Prescription Drug User Fee Act action date of April 25, 2023. Additional details about the advisory committee meeting can be found in a separate statement by Biogen which is available on their website." Reference Link

Biogen announced that on January 23, the Federal Register published a notice that the U.S. Food and Drug Administration will convene a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee for the New Drug Application, or NDA, for tofersen, an investigational product for the treatment of superoxide dismutase 1, or SOD1, amyotrophic lateral sclerosis, or ALS. "The advisory committee meeting is scheduled for March 22, 2023 and will be available for live streaming. The FDA intends to make the advisory committee meeting's background materials available to the public no later than two business days before the meeting, according to the notice. The FDA said if they are unable to post the background materials on its website prior to the advisory committee meeting, the background material will be made publicly available on the FDA's website at the time of the advisory committee meeting. SOD1-ALS is an ultra-rare genetic form of ALS that affects approximately 330 people in the U.S.1, it is progressive, leads to the loss of everyday functions and is uniformly fatal. Biogen's NDA for tofersen was accepted for priority review by the FDA under the accelerated approval pathway and has a Prescription Drug User Fee Act action date of April 25, 2023," Biogen stated. Reference Link

Eisai (ESALY) and Biogen (BIIB) announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer's disease, or AD, and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency, or PMDA, of Japan. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.