SEPTEMBER 30, 2022:
WASHINGTON (AP) — U.S. health officials have approved a much-debated drug to treat the deadly illness known as Lou Gehrig’s disease. The approval Thursday (Sept. 29, 2022) follows an intense lobbying campaign by patients and advocates, though it’s also likely to raise questions about the standards used to review experimental medicines. The Food and Drug Administration approved the medication from Amylyx Pharmaceuticals based on results from one small, mid-stage study. The agency’s internal scientists repeatedly said the company’s results were not convincing. But thousands of patients have urged the FDA to be flexible and grant patients’ access. Lou Gehrig’s disease has no cure and most patients die within five years of initial symptoms.
SEPTEMBER 8, 2022:
WASHINGTON (AP) — A panel of federal health advisers has voted to recommend approval for an experimental drug to treat Lou Gehrig’s disease. The ruling Wednesday (Sept. 7, 2022) 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.
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