KISSEI PHARMACEUTICAL CO.,LTD. [4547.T]
TOKYO, May 21 (Pulse News Wire) – Kissei Pharmaceutical CO.,LTD. (4547.T) issued a safety alert on May 15, 2026, concerning its drug Tabneos (generic name: Avacopan) used to treat microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).
According to the alert, the company revised the drug's package insert based on instructions from the Ministry of Health, Labour and Welfare, emphasizing the risk of severe liver dysfunction, which could lead to death. The revised insert advises regular liver function tests during treatment and careful monitoring of patients' conditions. In light of these risks, Kissei Pharmaceutical advised healthcare providers to temporarily refrain from prescribing Tabneos to new patients and to carefully assess the continuation of treatment for existing users.
Patients are urged to undergo thorough initial liver function testing upon starting the medication and regular checks thereafter to prevent serious complications. The company also emphasized the importance of consulting medical professionals rather than self-discontinuing the drug if any health changes occur. Further analysis of the potential impact on the company’s performance is ongoing.
Should significant effects on earnings become evident, Kissei Pharmaceutical will promptly disclose such information.
🟢 Confidence: High AI-translated content.