Josh Cohen (L) and Justin Klee (Amylyx)
After an about-face on a PhIII trial, FDA sets up an adcomm to review controversial ALS drug next month
Following a U-turn from the FDA, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee will meet on March 30 for an all-day teleconference to discuss what could be only the third ALS drug approved since 1995.
Although the potential drug from Amylyx, known as AMX0035, may work, the FDA previously sought another trial to confirm early positive results. The agency had asked Amylyx to conduct a Phase III study last April to see whether Phase II data from 2020 held up.
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