FDA Committee Backs ALS Drug as ICER Questions Projected Cost

  • Sep 08, 2022

    By a seven to two margin, an FDA advisory committee on Sept. 7 voted that there was enough evidence to support the approval of AMX0035, an oral medication that Amylyx Pharmaceuticals, Inc. is developing for amyotrophic lateral sclerosis (ALS). The vote represented a reversal for the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC), which on March 30 had recommended against the medication’s approval.  

    Despite the committee's decision, David Rind, M.D., chief medical officer of the nonprofit Institute for Clinical and Economic Review (ICER), tells AIS Health that Amylyx may have trouble getting the drug covered due to the medication’s likely high cost and lack of clear effectiveness.   

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  • Tim Casey

    Tim has worked as a reporter and editor for more than 20 years. Before joining AIS Health in December 2021, he was a business reporter covering the commercial real estate industry’s capital markets for four years. He previously covered health care business issues for two medical publishing companies and high school, college and professional sports for the Sacramento Bee newspaper. Tim has a B.A. in Psychology from the University of Notre Dame and an M.B.A. from Georgetown University.

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