Amylyx gets first approval for ALS drug from Canada

The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies. The approval for the drug, which will be sold in Canada under the brand Albrioza, is based on a mid-stage study in 137 patients and a long-term follow-up phase, which showed it slowed a decline in physical functioning among patients.

Canada has approved Amylyx Pharmaceuticals' treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the drugmaker said on Monday, the first such approval for the oral drug. The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies.

The approval for the drug, which will be sold in Canada under the brand Albrioza, is based on a mid-stage study in 137 patients and a long-term follow-up phase, which showed it slowed a decline in physical functioning among patients. ALS, whose cause is largely unknown, causes nerve cells in the brain and spinal cord to break down, affecting physical function and resulting in severe disability and death.

About 3,000 Canadians are currently living with ALS, with the average life expectancy from the symptom onset being two to five years, according to the company. Health Canada's approval comes ahead of a decision by the U.S. Food and Drug Administration, which is expected by Sept. 29.

A panel of outside advisers to the U.S. regulator had in March voted 6-4 against approving the drug for ALS, AMX0035, saying the clinical study data failed to establish it was effective against the disease. Commonly known as Lou Gehrig's disease, ALS entered the spotlight in 2014 due to the "Ice Bucket Challenge", which involved people filming themselves pouring ice-cold water over their heads to raise awareness.

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