Japanese partner urges caution on Tavneos use amid safety concerns and FDA scrutiny.

Kissei Pharmaceutical, Amgen's Japanese partner, has advised doctors to exercise caution when prescribing Tavneos (avacopan) due to safety concerns, including risks of liver dysfunction. This follows FDA warnings and a proposed withdrawal of Tavneos approval in the U.S. over data integrity issues and questionable effectiveness. In Japan, 20 deaths have been reported among Tavneos users, though causality is unclear. Kissei is coordinating with health authorities in Japan, the U.S., and Europe to ensure patient safety while the drug remains approved in Japan.