In 2022, ALBRIOZA was authorized under the NOC/c policy for the treatment of patients with ALS, based on results from a Phase 2 clinical study and pending the results of trials to verify its clinical benefit. ALBRIOZA is now available only to current patients under Amylyx Pharmaceuticals, Inc.’s Patient Support Program and should not be initiated in new patients. This is due to the results of a Phase 3 confirmatory study that did not meet its primary or secondary endpoints and led to the decision to withdraw the product from the market.
RecallTracker