Amylyx Pharma pulls ALS drug from US market as it didn’t help patients

CAMBRIDGE, Massachusetts: This week, Amylyx Pharmaceuticals, the maker of a drug for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, which recently failed in a major study, said it would pull the medicine from the U.S. market.

The company admitted that its ALS drug, Relyvrio, did not help patients with severe neurological conditions and announced that it would voluntarily stop selling and marketing the drug in the U.S. and Canada.

In a statement, Amylyx said, "While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS."

Patients of the fatal muscle-wasting disease who are already taking the drug but wish to continue can enroll in a program to receive it free of charge.

After an advocacy campaign by ALS patients, the Food and Drug Administration (FDA) approved Relyvrio in September 2022.

The drug’s failure forced the FDA and other federal agencies to fund and approve more experimental therapies for the disease. Currently, three ALS medicines are available to U.S. patients, and only one has been proven to extend survival by several months.

This week, the Cambridge, Massachusetts-based pharmaceutical company also said it will lay off 70 percent of its more than 350 employees due to a significant restructuring.

However, it plans to continue studying Relyvrio and another experimental drug for several rare diseases, including Wolfram syndrome, which causes diabetes and blindness during childhood.

Relyvrio is a powder that combines a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine.

Amylyx also faced criticism for pricing the drug at US$158,000 for a one-year supply.