Amylyx gets first approval for ALS drug from Canada – Reuters

June 13 (Reuters) – Canada has approved Amylyx Pharmaceuticals’ (AMLX.O) treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the drugmaker said on Monday, the first such approval for the oral drug.
The decision by Health Canada 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.
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.
Nearly 3,000 Canadians are currently living with ALS, commonly known as Lou Gehrig’s disease, the company said.
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.
Shares of the company rose 5.7% to $14.30 in early trading.
In the United States, a decision on the drug, AMX0035, by the Food and Drug Administration (FDA) is expected by Sept. 29.
The regulator had recently extended its review period by three months, citing the need for more time to review additional analyses of data from clinical studies.
The extension came after a meeting of its outside advisers declined to endorse the drug’s approval, saying the clinical study data failed to establish it was effective against the disease. read more
The disease came under 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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