The Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration will meet on June 10 to discuss the biologics license application forThe FDA delayed its decision on whether to approve the antiamyloid agent back in March, opting instead to hold a meeting of its outside experts to weigh the results of the phase 3
The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer's Disease Rating Scale , which measures cognition and activities of daily living. "It also wants to discuss the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels," said Wall.