The Food and Drug Administration is not required to follow the panel's advice, but its positive recommendation suggests an approval is likely later this month.
A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig's disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The Food and Drug Administration advisers voted 7-2 that data from Amylyx Pharma warranted approval, despite hours…
A panel of federal health advisers has voted to recommend approval for an experimental drug to treat Lou Gehrig s disease. The ruling Wednesday is a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The FDA previously held a meeting in March where the outside experts narrowly sided against Amylyx s drug, saying the company s data was unconvincing. Wednesday s meeting focused on new analyses which the company said strengthened its case for approval. Patients and their families have rallied behind Amylyx s drug, urging approval.