Last month, the company announced the top-line results from that 48-week, randomized, placebo-controlled trial involving 664 patients: Relyvrio failed to meet any of the trial’s goals. The drug did not improve patients’ physical functions, which were scored on a standardized ALS-specific test, nor did it improve quality of life, respiratory function, or overall survival. At that time, the co-CEOs of the company said they were “surprised and deeply disappointed” by the result, and the company acknowledged that it was considering voluntarily withdrawing the drug from the market.
I hope everyone who was taking this drug and the insurance companies that were backing them collectively sues this company, because as far as the article covers, there’s not even any mention of the fact that some number of ALS patients are out potentially hundreds of thousands of dollars which they probably wouldn’t have been had it not been for this company’s claims that the drug did what it was supposed to…
Patients already taking the medication who wish to continue taking it will be able to do so through a free drug program, the company said. It is no longer available to new patients, effective Thursday.
If you fell for our bogus study showing that this drug worked, and would now like to continue taking it despite the fact that it’s been shown to not work, we won’t charge you anymore!
Edit: From the article linked to in the article posted here, they note:
The F.D.A. decided to greenlight the drug instead of waiting until 2024 for results of a large clinical trial partly because the treatment is considered to be safe. The agency said that although the evidence of effectiveness was uncertain, “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.”
and
Amylyx officials predicted that most patients would pay little or nothing for the treatment because the company expects insurers, both private and public, to cover it. Amylyx plans to provide it free to uninsured patients experiencing financial hardship.
So maybe it’s not as bad but it’s still pretty fucking bad.
This is the best summary I could come up with:
However, the data behind the controversial decision was shaky at best; it was based on a study of just 137 patients that had several weaknesses and questionable statistical significance, and FDA advisors initially voted against approval.
Still, given the severity of the neurogenerative disease and lack of effective treatments, the FDA ultimately granted approval under the condition that the company was working on a Phase III clinical trial to solidify its claimed benefits.
In the announcement on Thursday, the company called Relyvrio’s market withdrawal a “difficult moment for the ALS community.”
Amylyx is now “restructuring” to focus on two other drug candidates that treat different neurodegenerative disease.
Relyvrio is part of a series of similarly controversial drugs for devastating neurodegenerative diseases that have gained FDA approval despite questionable data.
In January, drug maker Biogen announced it was abandoning Aduhelm, a highly contentious Alzheimer’s drug that failed two large trials prior to its heavily criticized approval.
The original article contains 388 words, the summary contains 155 words. Saved 60%. I’m a bot and I’m open source!
