PMDA · MHLW · monthly list
All drugs approved in Japan in February 2025, in English.
Last updated: 2026-10-02 · 7 approvals
Japan approved 7 drugs in February 2025 (approval date: 2025-02-20): 4 new indication, 2 new dosage, 1 new active ingredient. Median lag vs FDA for this month: -0.3 years (-116 days) (n=1).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-02-20 | Tecentriq テセントリク | Atezolizumab アテゾリズマブ(遺伝子組換え) | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of unresectable alveolar soft part sarcoma 切除不能な胞巣状軟部肉腫 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-02-20 | Sarclisa サークリサ | Isatuximab イサツキシマブ(遺伝子組換え) | Sanofi K.K. サノフィ(株) | Treatment of multiple myeloma 多発性骨髄腫 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-02-20 | Revlimid レブラミド | Lenalidomide hydrate レナリドミド水和物 | Bristol-Myers Squibb K.K ブリストル・マイヤーズスクイブ(株) | Treatment of multiple myeloma 多発性骨髄腫 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-02-20 | Lixiana リクシアナ | Edoxaban tosilate hydrate エドキサバントシル酸塩水和物 | Daiichi Sankyo Company, Limited 第一三共(株) | Prevention of thrombus/embolus formation in patients with chronic thromboembolic pulmonary hypertension 慢性血栓塞栓性肺高血圧症患者における血栓・塞栓形成の抑制 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2025-02-20 | Humira ヒュミラ | Adalimumab アダリムマブ(遺伝子組換え) | AbbVie GK アッヴィ(同) | Treatment of non-radiographic axial spondyloarthritis in patients who have not responded sufficiently to conventional treatments 既存治療で効果不十分なX線基準を満たさない体軸性脊椎関節炎 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2025-02-20 | Epkinly エプキンリ | Epcoritamab エプコリタマブ(遺伝子組換え) | Genmab K.K. ジェンマブ(株) | Treatment of relapsed or refractory follicular lymphoma (Grade 1 to Grade 3 A) 再発又は難治性の濾胞性リンパ腫(Grade 1~3A) | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2025-02-20 | Andembry S.C. アナエブリ | Garadacimab ガラダシマブ(遺伝子組換え) | CSL Behring K.K. CSLベーリング(株) | Prophylaxis of acute attacks of hereditary angioedema 遺伝性血管性浮腫の急性発作の発症抑制 | New active ingredient standard | 2025-06-16 | 2025-02-10 | 116 d earlier Japan first | 10 d 0.0 y | [1] [2] [3] [4] [5] |
Click a column header to sort. Lag = days between the FDA (or EMA) approval and the Japanese approval of the same active ingredient; “Japan first” means Japan approved it earlier. Lag is shown only when a matching foreign approval was found. JP = no English name found; Japanese kept.
Source: PMDA / MHLW (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.
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