Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concluded FY 2024‑25 (April 2024–March 2025) with a total of 148 approval decisions, including no less than 66 new active ingredients and 82 lifecycle updates, including new indications, pediatric expansions, and formulation changes.
Innovation Snapshot
A steady stream of orphan and rare‑disease designations—including sparsentan for primary IgA nephropathy and glycerol phenylbutyrate for urea cycle disorder— benefited from priority review pathways fostered by new orphan‑drug processes and advisory support launched in 2024.
This year saw approvals in key global hot sectors: metabolic disease (icodec, tirzepatide/Zepbound), autoimmune conditions (ulcerative colitis, Crohn’s), rare pediatric renal disorders, and Alzheimer’s advances including Donanemab and Tauvid diagnostic PET agents.
Lifecycle Expansion Frenzy
More than 40 partial label changes broadened usage of major brands (Humira, Dupixent, Jakavi), enhancing access and flexibility for clinicians and patients.
Full List
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