Amylyx Pharmaceuticals Inc.’s controversial treatment for amyotrophic lateral sclerosis won the support of a panel of U.S. regulatory advisers, putting the product on track for likely clearance.
During a rare second panel meeting on Wednesday, the Food and Drug Administration’s peripheral and central nervous system drugs advisory committee voted 7-2 to back approval of the treatment. Trading in the shares was halted.
During an initial meeting in March, FDA advisers found that data from Amylyx’s relatively small initial trial was insufficient to prove that AMX0035 slowed ALS progression. The negative decision put the FDA in a bind, as the agency, under pressure from disease activists, has promised to exercise flexibility in approving drugs for dire illnesses such as ALS, given the urgent need for better treatments.
