FDA staff raises efficacy concerns for Otsuka's PTSD combination drug
16/07/2025 14:10
July 16 (Reuters) - The U.S. Food and Drug Administration's staff reviewers on Wednesday raised efficacy concerns over Otsuka Pharma's 4578.T combination treatment for adults with post-traumatic stress disorder (PTSD), citing inconsistent trial results and a modest treatment effect that may not be clinically meaningful. (Reporting by Siddhi Mahatole and Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Shreya Biswas) ((siddhi.mahatole@thomsonreuters.com;))
Recent news on Otsuka Holdings
See all newsOtsuka, Ionis' experimental ALS drug meets main goal in late-stage study
Brief: Otsuka Pharmaceutical Announces Ulefnersen Early Access Program For Eligible People Living With FUS-ALS
Brief: Otsuka Pharmaceutical Says Phase 3 Fusion Results For Ulefnersen Met Primary Endpoint
Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit In Rezilient3 Phase 3 Trial In First-Line Egfr Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Climb Bio rises after early-stage data for kidney disease drug