FILE - This image provided by Amylyx Pharmaceuticals shows the drug Relyvrio. The maker of a much-debated drug for Lou Gehrig’s disease said Friday, March 8, 2024 its therapy failed to help patients in a large follow-up study, but stopped short of committing to follow through on a prior pledge to pull the drug from the U.S. market.
In a highly unusual move, company executives at the meeting told FDA regulators they would voluntarily pull their drug from the market if follow-up research didn’t confirm that it helps. That commitment seemed to reassure FDA’s advisers who voted in favor of the drug’s approval, despite the questionable data.
Amylyx’s drug did not qualify for that type of approval because its studies are mostly based on patient-reported questionnaires and other data that FDA does not use to expedite drug approvals.
Health Health Latest News, Health Health Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Source: BestLifeOnline - 🏆 533. / 51 Read more »