The Manufacturer of ALS Drug Relyvrio Says It Will Be Withdrawn

( – Before pharmaceutical companies release new drugs, they undergo multiple phases of rigorous testing to ensure that they’re safe and efficient. Over time, some may be removed from the market if they fail to do what they advertise or cause too many adverse reactions. That’s exactly what Amylyx Pharmaceuticals is doing with Relyvrio, or Albrioza, as it’s known in Canada.

Lou Gehrig’s Disease Treatment

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease, is a debilitating neurodegenerative disease affecting nerve cells in the spinal cord and brain. People with the illness slowly lose the ability to move their muscles, eventually resulting in complete paralysis of every part of their body. There’s no known cure for it, only medication that can help manage symptoms so those with the condition can live longer lives or experience loss of function at a slower rate.

In 2022, after a long review process that saw independent advisers and agency reviewers questioning its effectiveness, the Food and Drug Administration (FDA) approved Relyvrio for the treatment of the disease and it was released to the public. The company’s chief executive officers promised to remove it from the market if it failed the Phase 3 trial.

When the results of a 48-week trial involving 664 participants who tried the medication came out, it revealed that Ryelvrio was no better than a placebo, effectively proving what analysts had already said. Afterward, the manufacturer, Amylyx Pharmaceuticals, said it would consider taking it off the market. The company has since decided to do so.

The Announcement

On Thursday, April 4, co-Chief Executive Officers Joshua Cohen and Justin Klee announced that the company was, indeed, pulling the medication. They noted it was a “difficult moment for the A.L.S. community,” but they had “reached this path forward in partnership with the stakeholders who will be impacted” and “steadfast commitment to people living with” the disease.

Unfortunately, the move also means that there will be a drastic 70% reduction in the workforce. The company plans to move ahead with continuing how the medication could help in treating two rare diseases: progressive supranuclear palsy and Wolfram syndrome.

Amylyx is also facing a class-action lawsuit from investors who claim the company overstated the drug’s commercial prospects and failed to reveal that there were fewer new prescriptions and patients were discontinuing use after six months.

What Does It Mean for Those Taking the Medication?

Those who are already taking the medication and wish to continue will transition to a free drug program. However, the drug’s removal from the market means that doctors will not prescribe it as of Thursday, April 4.

Copyright 2024,