The drug, Relyvrio, is the third U.S.-approved medicine for amyotrophic lateral sclerosis, or ALS, which destroys nerve cells needed for basic functions like walking, talking and swallowing.
The FDA’s review has become a flashpoint in broader debates about the regulatory agency, including how flexible it should be when reviewing drugs for deadly diseases and how much weight it should give to appeals from patients and other outside voices.
In an online memo summarizing its decision, the FDA said “regulatory flexibility” was appropriate for approving Relyvrio, “given the serious and life-threatening nature of ALS and the substantial unmet need.” That outpouring helped sway the same expert panel when FDA reconvened them earlier this month to revisit Amylyx’s drug. The second time around, they backed the drug, 7-2. The vote was not binding, but it seemed to open the door for FDA approval.
This 2018 photo provided by Amylyx shows the company's co-founders Joshua Cohen, left, and Justin Klee in Cambridge, Mass. A much-debated drug for Lou Gehrig’s disease, made by Amylyx, won U.S. approval Thursday, Sept. 29, 2022, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.
Sunny Brous was diagnosed with ALS in 2015 and hopes to add Relyvrio to the two older FDA-approved medications she already takes for the disease.
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