FDA panel backs a much-debated ALS drug in a rare, second review
The ruling is a remarkable turnaround for the much-debated medication that was previously rejected by the same group this year.
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.