Amylyx prices newly approved ALS drug at $158,000 per year

Sept 30 (Reuters) – Amylyx Pharmaceuticals Inc (AMLX.O) on Friday set the list price of its newly approved drug to treat amyotrophic lateral sclerosis (ALS) at about $158,000 per year in the United States, a discount to its most recently approved competitor.

The drug Relyvrio was approved by the U.S. Food and Drug Administration on Thursday, making it the third ALS treatment to get the regulator’s nod after Japanese firm Mitsubishi Tanabe’s Radicava, priced at around $170,000 per year, and the generic drug riluzole. read more

Amylyx priced the drug at around $12,500 per 28-day prescription, Chief Commercial Officer Margaret Olinger said in an investors’ conference call.

The company also plans to provide the drug at no cost to U.S. patients that are uninsured or underinsured, under certain conditions, Olinger said.
The drug should have been priced closer to the cost of production until there was clear proof about its efficacy, said David Rind, chief medical officer at independent drug pricing watchdog Institute for Clinical and Economic Review.

“We believe the manufacturer in a situation like this has an obligation to price responsibly,” Rind said, adding the drug is currently priced at more than five times higher than the top of a value-based range.

Data from a late-stage trial of around 600 patients is expected in 2024, with most patients now being enrolled in Europe, co-chief executive officers Justin Klee and Joshua Cohen told Reuters in an interview.

Klee and Cohen said they arrived at the price after discussions with patients, insurers and other stakeholders while also looking at funding future research.

ALS, which can lead to progressive paralysis and death, affects more than 30,000 patients in the United States.
Relyvrio is the first drug funded by the ‘Ice Bucket Challenge’ in 2014 to get FDA approval. The challenge helped the patient advocacy group ALS Association raise over $115 million.

Reporting by Leroy Leo and Mrinalika Roy in Bengaluru; editing by Uttaresh.V and Krishna Chandra Eluri

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