Amylyx said last month it was considering pulling its drug Relyvrio after a clinical trial in 600 patients failed to show any improvements in survival or other health measuresThe maker of a drug for Lou Gehrig’s disease that recently failed in a large study said Thursday it will pull the medicine from the market, acknowledging it didn't help patients with the deadly neurological condition.
Feeling out of the loop? We'll catch you up on the Chicago news you need to know. Sign up for the weeklyThe drug's failure is a bitter disappointment for patients and advocates, who have pressed the FDA and other federal agencies to fund and approve more experimental therapies for the fatal muscle-wasting disease.
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.
ALS gradually destroys the nerve cells and connections needed to walk, talk, speak and breathe. Most patients die within three to five years of a diagnosis.
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