Amgen Inc.’s (NASDAQ:AMGN) Japanese partner Kissei Pharmaceutical Co., Ltd. said it has started information-sharing activities in Japan, urging healthcare professionals to carefully evaluate the use of Tavneos (avacopan) following safety and regulatory concerns raised in the U.S. and Europe.

Kissei Advises Doctors To Exercise Caution On Tavneos

The company said physicians should avoid prescribing the drug to new patients and reassess continued treatment for current users while considering risks tied to liver dysfunction and available alternative therapies.

Tavneos has been marketed in Japan since June 2022 for microscopic polyangiitis and granulomatosis with polyangiitis.

Kissei obtained exclusive rights for the drug's development and commercialization in Japan from CSL Vifor in 2017.

The Wall Street Journal reported, citing Kissei, that 20 people in Japan died after taking Tavneos, though it's unclear whether the drug was the cause of the deaths.

FDA Warning And Proposed Withdrawal Raise Concerns

Kissei's announcement follows actions by U.S. regulators ...