FILE - This image provided by Amylyx Pharmaceuticals shows the drug Relyvrio. The maker of a drug for Lou Gehrig’s disease that recently failed in a large study said Thursday, April 4, 2024 it will pull the medicine from the U.S. market, acknowledging it didn’t help patients with the deadly neurological condition. said Thursday it will pull the medicine from the market, acknowledging it didn’t help patients with the deadly neurological condition.
“While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS,” company co-founders said in a statement. Patients already taking the therapy who wish to continue will be able to enroll in a program to receive it for free.West Virginia Gov.
The company’s voluntary action resolves what could have been a major dilemma for the FDA. The agency’s regulators would not have had a clear path to quickly force the drug from the market if the company had refused to remove it. That’s because the FDA granted the drug full approval, despite the preliminary nature of the company’s data on effectiveness.by some of the agency’s own internal scientists.
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