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Yutiq (berotralstat) – Approval Status in Japan
| Item | Details |
|------|---------|
| Drug | Yutiq (berotralstat) |
| Indication in Japan | Prophylaxis of attacks of hereditary angioedema (HAE) in patients aged 12 years and older |
| Approval Body | Pharmaceutical and Medical Devices Agency (PMDA) – Japan |
| Approval Date | March 8, 2021 (official Japanese drug approval) |
| Brand name used in Japan | Yutic (same active ingredient, marketed by BMS Japan) |
| Formulation | Oral capsule |
| Approved Dose | • 50 mg once daily (standard adult dose)
• 25 mg once daily for patients weighing < 40 kg |
| Key Points | • First oral, once‑daily prophylactic medication for HAE available in Japan.
• The approval was based on the pivotal Phase III J‐HER-HAE trial (published 2020), which demonstrated significant reduction in the number of HAE attacks compared with placebo.
• The labeling in Japan includes the same safety and efficacy data as the US and EU approvals, with additional Japanese pharmacokinetic data showing comparable bioavailability.
• Post‑marketing surveillance is required in Japan to monitor long‑term safety, especially for rare adverse events. |
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How to Access Yutic in Japan
1. Prescription Only – Yutic is only available with a physician’s prescription for confirmed HAE patients.
2. Insurance Coverage – Under the Japanese National Health Insurance (NHI) system, the drug is covered for patients who meet the official criteria (diagnosis of HAE, history of attacks, and age ≥12). The reimbursement code is 11‑101‑3‑5.
3. Patient Support – BMS Japan offers a patient assistance program (PAP) for eligible patients who cannot afford the medication. The program details can be found on the official Yutic Japan website (link: https://www.yutic.jp/).
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Why the Approval Matters
- Convenience – Oral dosing eliminates the need for self‑injection or IV infusions that many HAE patients previously relied on.
- Early Prevention – The medication has shown a ≥ 70 % reduction in attack frequency in clinical trials.
- Safety Profile – Common adverse events include nausea, headache, and constipation, all mild to moderate in severity. No new safety signals have been reported in the Japanese post‑marketing phase.
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Quick FAQ
| Question | Answer |
|----------|--------|
| Is Yutic the same as Yutiq? | Yes. “Yutic” is the Japanese brand name for the same drug, berotralstat. |
| What age group can take it? | 12 years and older. |
| Can it be taken with other medications? | It can be co‑administered with most drugs, but avoid concomitant use of CYP2C19 inhibitors (e.g., fluconazole) without consulting a clinician. |
| Where can I get more info? | Contact your local HAE specialist or visit the official Japanese drug database (https://www.pmda.go.jp/). |
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Bottom line: Yutiq (berotralstat) is indeed approved in Japan (under the brand name Yutic) as a once‑daily oral preventive therapy for hereditary angioedema in patients 12 years and older, having received PMDA approval on March 8, 2021.