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Amylyx Pharmaceuticals to Remove ALS Drug From the Market
Amylyx Pharmaceuticals recently made a significant announcement regarding their ALS drug, Relyvrio, which has been pulled from the market due to clinical trial results indicating ineffectiveness. The company also disclosed plans for corporate restructuring and laid off 70 percent of its staff.
Background on Relyvrio Approval and Controversy
Relyvrio received FDA approval in September 2022 as a treatment to slow the progression of ALS. However, the approval was based on a study involving only 137 patients, leading to concerns about the reliability and statistical significance of the data. FDA advisors initially opposed the approval but eventually granted it under the condition that a Phase III trial would be conducted to verify the drug’s benefits.
With a list price of $158,000, Relyvrio comprised a combination of two existing generic drugs when it entered the market.
Outcome of the Clinical Trial
After completing a 48-week, randomized, placebo-controlled trial involving 664 patients, Amylyx Pharmaceuticals announced the disappointing results that Relyvrio did not meet any of the trial’s goals. The drug failed to improve physical functions, quality of life, respiratory function, or overall survival of ALS patients as expected.
The co-CEOs expressed their surprise and disappointment in the results and are considering withdrawing the drug voluntarily from the market.
Market Withdrawal and Impact on the ALS Community
In the recent announcement, the company stated that the withdrawal of Relyvrio from the market was a challenging decision for the ALS community. Existing patients who wish to continue the medication can do so through a free drug program, while new patients are no longer eligible for treatment with Relyvrio.
Company Restructuring and Future Focus
Following the market withdrawal of Relyvrio, Amylyx Pharmaceuticals is shifting its focus to two other drug candidates for different neurodegenerative diseases. To facilitate this transition, the company has laid off 70 percent of its workforce, impacting over 350 employees, according to The Washington Post.
The scenario with Relyvrio adds to a series of controversies surrounding FDA-approved drugs for neurodegenerative diseases based on questionable data. In a similar situation, Biogen recently abandoned Aduhelm, an Alzheimer’s drug, after failed trials and widespread criticism.
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