Kissei Restricts TAVNEOS Use in Japan After Global Safety and Data Concerns

Kissei Pharmaceutical Co ( (JP:4547) ) has shared an announcement.

Kissei Pharmaceutical has begun an information campaign urging Japanese healthcare professionals to avoid starting new patients on TAVNEOS and to reassess ongoing treatments, after U.S. and European regulators raised serious concerns over the drug’s safety and data integrity. The U.S. FDA has warned of severe drug-induced liver injury, proposed withdrawing approval on grounds of insufficient evidence and misstatements in the original application, while the EMA has opened a review of phase III trial data.

Although TAVNEOS remains approved in Japan, Kissei is working with the PMDA and the Ministry of Health, Labour and Welfare, and is directing physicians to detailed guidance on appropriate use and alternative therapies to safeguard patients. With TAVNEOS generating ¥11.524 billion in sales in the year to March 2026, the company is still assessing the potential impact on its earnings and market position in the rare disease segment.

The most recent analyst rating on (JP:4547) stock is a Buy with a Yen5400.00 price target. To see the full list of analyst forecasts on Kissei Pharmaceutical Co stock, see the JP:4547 Stock Forecast page.

More about Kissei Pharmaceutical Co

Kissei Pharmaceutical Co., Ltd. is a Japan-based drug maker listed on the Tokyo Stock Exchange Prime Market that focuses on specialty therapies, including treatments for rare kidney and inflammatory diseases. In Japan it markets TAVNEOS (avacopan), an oral C5a receptor antagonist licensed from CSL Vifor for microscopic polyangiitis and granulomatosis with polyangiitis, both designated intractable diseases.

Average Trading Volume: 93,024

Technical Sentiment Signal: Buy

Current Market Cap: Yen179.3B

Learn more about 4547 stock on TipRanks’ Stock Analysis page.