The drug is now unavailable to new patients; its maker to lay off 70% of employees.

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.

  • @KoboldCoterie@pawb.socialEnglish
    2•9 months ago

    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.