Posted by Michael Wonder on 03 Aug 2022
Amylyx Pharmaceuticals announces FDA Advisory Committee will reconvene to review new drug application for AMX0035 for the treatment of ALS
3 August 2022 - Amylyx Pharmaceuticals today announced that the U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee will reconvene to review the new drug application for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis.
The second virtual meeting of the Committee to discuss the AMX0035 new drug application is scheduled, as published in the Federal Register, for 7 September 2022.
