
From left to right: Amylyx Co-founders and Co-CEOs Josh Cohen and Justin Klee (Photo courtesy of Amylyx)
A biotechnology company expects to get a rare second chance to try to win the support of a key federal panel for an experimental treatment, in this case, a medicine intended to treat a devastating neurological condition, amyotrophic lateral sclerosis, commonly known as ALS.
Amylyx Pharmaceuticals Inc. on July 5 announced that it expects the Food and Drug Administration (FDA) to hold an advisory committee meeting on Sept. 7 about the company’s experimental ALS treatment. The Cambridge, Massachusetts-based company said it expects discussion at this meeting to focus on additional analyses of data from research done on the treatment or AMX0035. (AHCJ has created a tip sheet for covering FDA advisory committee meetings held about experimental medicines or new uses of approved drugs.
The FDA has a target date of Sept. 29 for deciding on whether to clear AMX0035. This deadline was extended from June 29 to allow more time for the FDA to review additional analyses of data, Amylyx said. The company suffered a setback in March when the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 to say that evidence gathered to date had not proven the treatment works. The FDA considers the recommendations of its advisory panels, but it is not bound by them.