Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Termination and Reestablishment

 summary of the previous accomplishments of the committee and the reasons it needs to continue: Summary of Previous Accomplishments: In 2024, the Peripheral and Central Nervous System Drugs Advisory Committee held one meeting: June 10, 2024: Discuss biologics license application 761248, for donanemab solution for intravenous infusion, submitted by Eli Lilly and Co., for the treatment of early symptomatic Alzheimer's disease. In 2023, the Peripheral and Central Nervous System Drugs Advisory Committee held three meetings: March 22, 2023: Discussed new drug application (NDA) 215887, for tofersen (BIIB067) intrathecal injection, submitted by Biogen Inc., for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. April 14, 2023 (joint meeting with the Psychopharmacologic Drugs Advisory Committee): Discussed supplemental new drug application (sNDA) 205422 s009, efficacy supplement for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer's dementia. June 9, 2023: Discussed supplemental biologics license application (sBLA) 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of Alzheimer's disease, initiated in patients with mild cognitive im