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Amylyx Pharmaceuticals announced On Thursday, it began the process of voluntarily removing the ALS drug Relyvrio from the market after it failed to prove its effectiveness in a large clinical trial.
“Relyvrio will not be available to new patients as of today. Patients who are currently on treatment in the US and Canada and wish to remain on treatment in consultation with their physicians may transfer to the free drug program,” Amylix said. News release.
Results A large Phase 3 clinical trial released in early March showed that Relivrio improved participants' ALS functional scale after 48 weeks, measuring their ability to breathe, swallow and speak, no better than placebo. In addition, the patient-reported quality of life, overall survival and respiratory function did not significantly improve.
Amlix said it will continue to review and share findings from the clinical trial to inform future ALS research. The company will cut its workforce by roughly 70 percent to prioritize funding for an experimental drug for Wolfram syndrome and supranuclear palsy — both rare neurodegenerative disorders — and another for ALS, the news release said.
“We thank Amlix for taking Relievion off the market while ensuring that people living with ALS can get the drug if they believe it is helping them,” the nonprofit ALS Association said in a statement. “ALS is a fatal and heterogeneous disease with very few treatment options, and innovative solutions are needed.”
ALS, also known as Lou Gehrig's disease, affects up to 30,000 people in the United States. It is a fatal neurodegenerative disease that kills the nerves that control muscles, affecting the ability to move, speak, swallow and eventually breathe. US Centers for Disease Control and Prevention. The average time from symptom development to death is two to five years.
Relyvrio It has been accepted Based on a small phase 2 trial from the US Food and Drug Administration in September 2022, it showed modest improvement in disease in people who received the drug. That was the decision. Controversial At the time, experts said, proof of the drug's effectiveness was insufficient by normal FDA standards, but lobbying by ALS patient advocacy groups and a promise from the company that it would consider withdrawing the drug if the largest clinical trial failed were accepted.
“Safe and effective treatments can be made available quickly until further research proves their effectiveness,” the ALS Association said in a statement. “There are more than 40 potential treatments in the pipeline and we are focused on trying to advance safe and effective ones as quickly as possible.”