The top row
Drugmaker Amylyx Pharmaceuticals announced Thursday that it plans to pull Relyvrio from the market after inconclusive results from a phase III trial, leaving only two other ALS drugs on the market.
This image provided by Amylyx Pharmaceuticals shows the Relyvrio drug box.
Basic elements
Relyvrio (also known as Albrioza in Canada) is used to treat amyotrophic lateral sclerosis (ALS), a fatal and progressive neurodegenerative disease that affects the brain and nerve cells in the spinal cord.
The process to remove the drug from the market in both Canada and the U.S. will begin Thursday, and it will no longer be available to new patients, although current patients who wish to continue taking the drug can do so for free, according to that of the company announcement.
The Results of the 48-week phase III trial involving 664 participants was announced in March, and researchers concluded that the drug was no better than placebo, although researchers still considered it safe as no new side effects occurred.
After the results of the trial were announced, the monitoring group Public Citizen he urged the drug manufacturer to remove Relyvrio from the market. the group previously asked the Food and Drug Administration not to grant approval for the drug in 2022 because the results of the phase II trial were “inconclusive.”
Relybrium granted haste approval by the FDA in September 2022 after an FDA advisory panel initially said in the spring of 2022 that phase II trial results did not prove the drug was effective, though it changed pace later that year.
The advisory committee wrote to a summary after approving that there was still “uncertainty about the evidence of effectiveness,” but moved to approve it because ALS is life-threatening and serious, so “this level of uncertainty is acceptable in this case.”
Crucial passage
“The decision to take Relyvrio/Albrioza off the market and provide free treatment to those who wish to continue was informed by the results of the PHOENIX trial, collaboration with regulatory authorities and discussions with the ALS community,” Joshua Cohen and Justin Klee. Amylyx Pharmaceuticals co-CEOs said in a statement.
What to watch out for
Relyvrio is the brand name for sodium phenylbutyrate and taurosodiol, or AMX0035. Amylyx Pharmaceuticals said in a statement Thursday that it will continue to advance AMX0035 for treatment in Wolfram syndrome, which commonly causes diabetes and vision loss in children. The results of the phase II trial will be announced on April 10 during a company webcast. The company will reduce its workforce by 70% to focus on this and other upcoming clinical milestones.
Big number
381 million dollars. That’s how much Relyvrio generated in sales in 2023, according to Amylyx Pharmaceuticals’ full-year financials report. The drug made $49 million in profits that same year.
Key background
Only two other ALS drugs have received FDA approval. Riluzole was approved in 1995 and works by blocking the release of glutamate, a neurotransmitter that is part of the nervous system, according at the University of Michigan. Too much glutamate can potentially damage nerve cells. according on MedlinePlus of the National Library of Medicine. They are typical extends life expectancy by two to three months, and increases the chances of another year of survival by about 9%. The second drug called edaravone was approved in 2017 and works by slowing down nerve damage caused by worsening ALS symptoms. It slows progression by about 33%, which may equate to four to five extra months of survival compared with riluzole, according to a 2020 study published in the Canadian Medical Association Journal.
Further reading
ALS drug fails major clinical trial and may be pulled from market (CNN)
