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April 19, 2024

FDA-approved ALS Drug to be Pulled From Market After Failing Clinical Trial

Despite being one of the few medications approved by the FDA to treat amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s Disease, the value of Relyvrio has now been brought into question. According to AP, concerns regarding the drug existed at the time of approval almost two years ago. FDA reviewers acknowledged that there was insufficient evidence to know for certain effectiveness of the medication as ALS treatment. Nevertheless, due to a high demand for treatment as well as a pledge to conduct future clinical trials, the drug was approved.

As promised, however, a large clinical trial was conducted to determine the drugs actual efficacy. The 48-week trial consisted of more than 600 patients being treated for their ALS condition with either Relyvrio or a placebo. Much to the dismay of the drug’s users and producers, the results of the study would be less than encouraging. Findings indicated not only that Relyvrio failed to slow the development of the disease any more than the placebo treatment, but it also failed to improve secondary measures, such as muscle strength.

This news comes as a major blow to Amylyx, the drug manufacturer, who had said at the time of approval that it would voluntarily pull the drug from the market if it failed the clinical trials. Staying true to its word, the company announced on April 4, 2024 that it would be discontinuing the marketing authorizations for Relyvrio. Thus, with the removal of Relyvrio from the market, there are only six remaining drugs approved by the FDA for treating ALS and its symptoms.

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