The agency’s top five represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
Following a favorable vote from an FDA advisory committee, Amylyx is one step closer to seeing its amyotrophic lateral sclerosis (ALS) treatment approved for use in the United States.
Wednesday offers a rare opportunity for Amylyx Pharmaceuticals, which will go before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee in a second attempt to win recommendation for its amyotrophic lateral sclerosis (ALS) drug, AMX0035.
The agency will reconvene a meeting of its outside experts to review the company’s application seeking approval for its amyotrophic lateral sclerosis (ALS) treatment.
Canada has approved Amylyx Pharmaceuticals’ treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the first such approval for the oral drug. The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies.