Six members of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted not to approve Amylyx Pharmaceuticals’ new drug application (NDA) for the company’s amyotrophic lateral sclerosis (ALS) candidate AMX0035, while four voted yes.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Biogen’s Alzheimer’s disease medicine Aduhelm (aducanumab), which has a list price of $56,000 per year.
A third member of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee resigned in protest over the regulatory agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease.
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to Biogen’s experimental drug aducanumab for Alzheimer’s disease in a JAMA article.