Amylyx Pharmaceuticals will just take its ALS drug Relyvrio off the industry in the U.S. and Canada, ending a multi-year saga for clients with the rare neurodegenerative illness.
Relyvrio was accredited by the Foods and Drug Administration in 2022, dependent on facts that showed a modest slowing of sickness progression. The acceptance was contentious — regulators initially recommended Amylyx not to file for approval till it had conducted one more check, but ultimately cleared the drug. Amylyx’s co-CEOs Joshua Cohen and Justin Klee also publicly promised that they would withdraw the drug if additional tests failed to clearly show a advantage.
That actual scenario came to bear previous month, when Amylyx introduced that a Section 3 research involving 664 men and women failed.
Keep on to STAT+ to go through the full story…