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ALS drug pulled from market in Canada, U.S. after failing late-stage clinical trial

Amylyx Pharmaceuticals said Thursday it will withdraw its amyotrophic lateral sclerosis (ALS) drug from the market in Canada and the U.S. following its failure in a late-stage clinical trial.

The ALS drug, branded Albrioza in Canada and Relyvrio in the U.S., was approved in both countries in 2022.

ALS causes progressive paralysis and death. Each year about 1,000 Canadians die from the disease and about the same number are diagnosed, according to the ALS Society of Canada’s website. ALS affects roughly 60,000 people in the U.S. and Europe.

There are few options to treat the potentially fatal disease.

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Herman Jacobs says he often needs to make an “exhausting” 10-minute trip in his wheelchair to retrieve his parcels, when they are supposed to be dropped off at his door.

The medication is Amylyx’s only product on the market. The drug will no longer be available to new patients.

“Patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program,” the Cambridge, Mass., company said in a release.

The drug failed to outperform a placebo on a scale that measures the ability of patients to perform tasks such as walking, breathing, speaking and swallowing.

The company did not provide detailed results, but the numbers cited suggest the drug provided no benefit.

Dr. Angela Genge, a neurologist in Montreal and director of the Amyotrophic Lateral Sclerosis (ALS) clinic at The Neuro, called the announcement disappointing but not discouraging.

“We were very hopeful that this was a new product that would help us in the fight against ALS, but pleased that the company kept their word in the decision to take the drug off the market if the confirmatory study was negative,” Genge said in an interview. 

Genge said the ALS community is using and testing several new pills and injections targeted to what happens in the disease. 

Lack of ‘substantially persuasive’ data

Approval followed a rare turnaround by the U.S. Food and Drug Administration’s advisers. They backed the drug months after rejecting it for a lack of “substantially persuasive” data.

The approval was based on mid-stage trial data in 137 patients that showed the treatment slowed disease progression and extended life expectancy.

However, a larger late-stage study failed to confirm the reported benefit of slowing disease progression, with no significant difference in patients treated with the drug and a placebo.

The drug, which has a list price of $158,000 US per year in the U.S., generated sales of about $381 million US in 2023.

Amylyx said it plans to present the data from its Phoenix clinical trial at an upcoming medical meeting and will publish the results in a medical journal later this year.

Amylyx also announced a 70 per cent reduction in its workforce. At the end of 2023, the company had 384 full-time employees.

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