Despite Questionable Data, Drug for Lou Gehrig’s Disease Wins FDA Approval

Why TikTok, the FDA Moved Quickly to Squash #NyquilChicken Trend: ‘It's Not Worth Putting Yourself and Others at Risk'

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 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.

Some ALS patients already take both drugs separately, sometimes paying $5,000 a month for the prescription component, according to physicians. FDA approval is expected to compel insurers to cover Amylyx's medication. 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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Much-debated drug from Amylyx for Lou Gehrig’s disease wins FDA approvalA much-debated drug for Lou Gehrig’s disease won U.S. approval on Thursday from the Food and Drug Administration. Wdc
Source: FOX10Phoenix - 🏆 83. / 68 Read more »

Much-debated drug from Amylyx for Lou Gehrig’s disease wins FDA approvalA much-debated drug for Lou Gehrig’s disease won U.S. approval on Thursday from the Food and Drug Administration. Wdc
Source: FOX10Phoenix - 🏆 83. / 68 Read more »