The "approval in Canada could only further increase the pressure that the FDA faces to rule favorably and to approve this product," but the FDA should still wait for the phase 3 trial results, said Alexander, an internist and epidemiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Caleb Alexander, a member of the FDA's independent advisory panel, told the Times. There is a desperate need for effective ALS therapies, but when it comes to Albrioza, "it's unfortunate, but the magnitude of unmet need is not matched by the quality of evidence to date," Dr. 29, to review additional data from Amylyx. The FDA recently extended its deadline for a final decision to Sept. In a close vote in March, an independent panel of advisers to the FDA concluded that Albrioza was not ready for approval by the agency. There are only two approved ALS medications in the United States: riluzole, which can extend survival by several months, and edaravone, which can slow disease progression by about 33%, the New York Times reported.Įarlier this year, an FDA review of the drug said it was safe, but there was insufficient evidence that it helped patients live longer or slowed their loss of crucial functions such as muscle control, speaking or breathing without assistance, the Times reported. a statistically significant and clinically meaningful impact on function, alone or in addition to existing ALS therapies," Justin Klee and Joshua Cohen, co-CEOs and co-founders of Amylyx, said in a company statement.ĪLS (amyotrophic lateral sclerosis) - also known as Lou Gehrig's disease - often causes death within two to five years after diagnosis. We are excited with Health Canada's decision to approve Albrioza with conditions. "For nearly a decade, we have been committed to creating more meaningful moments for people living with ALS and their families. That includes verifying the "clinical benefit of this drug" with data from an ongoing phase 3 clinical trial expected to conclude in 2024, additional pharmacological studies and periodic safety reports. Food and Drug Administration has raised questions about its effectiveness.Ī condition of Health Canada's approval of Albrioza (AMX0035) calls for Massachusetts-based drug maker Amylyx Pharmaceuticals later to provide better evidence that the treatment is effective. MONDAY, J- An experimental drug for the neurological disorder ALS was approved in Canada on Monday, but an ongoing evaluation of the treatment by the U.S. New ALS Drug Approved in Canada While Still Under FDA Review
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