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.
"We've made a commitment at every point to act with integrity, to do the right thing, to follow the science," Cohen says."That's what we tried to do here.""I think Amylyx did right," says Brooke Eby, a Maryland resident who is 35 and living with ALS."I hope it sets a good example for the future."Experts and advocacy groups agreed. The ALS Association applauded Amylyx for"working closely with the ALS community.
"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.
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Fonte: NPR - 🏆 96. / 63 Consulte Mais informação »