When Amylyx Pharmaceuticals found out its ALS drug Relyvrio didn't work, the company took the unusual step of voluntarily pulling it off the market.In college, Amylyx cofounders Josh Cohen and Justin Klee dreamed of finding a treatment for diseases like ALS. When their drug's promise did not pan out, they pulled it voluntarily from the market.In college, Amylyx cofounders Josh Cohen and Justin Klee dreamed of finding a treatment for diseases like ALS.
Experts and advocacy groups agreed. The ALS Association applauded Amylyx for"working closely with the ALS community." And so did some experts who have criticized the FDA's decision to approve Relyvrio., an assistant professor of medical ethics and health policy at the University of Pennsylvania."But they didn't have to," she adds,"and that's concerning.
"If the Phoenix trial is not successful, we will do what's right for patients, which includes taking the drug voluntarily off the market," Klee told regulators."We have chosen not to partner and to stay independent," Klee said in a 2020 interview."We want to make sure that this is delivered responsibly in the right way for the community."
Accelerated approval allows the FDA to get a new drug on the market while still requiring the maker to conduct additional studies that will show whether patients benefit. If those studies fail to show a benefit, the agency has a path to removing the drug from the market.