They backed the drug months,! Corruption ? Insiders ? ugh ! Approval followed a rare turnaround by the U.S. Food and Drug Administration's advisers. They backed the drug months after rejecting it for a lack of "substantially persuasive" data.
The approval was based on mid-stage trial data in 137 patients that showed the treatment slowed disease progression and extended life expectancy.
However, a larger late-stage study failed to confirm the reported benefit of slowing disease progression, with no significant difference in patients treated with Relyvrio and a placebo.
The drug, which has a list price of $158,000 US per year in the U.S., generated sales of about $381 million US in 2023.
ALS drug pulled from market in Canada, U.S. after failing late-stage clinical trial | CBC News