Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, which was convened to reconsider whether the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) should be approved for treating amyotrophic lateral sclerosis, Public Citizen argued against approval because additional analyses of data from a clinical trial of the drug again failed to provide substantial evidence of effectiveness.