Amgen Japanese Partner Urges Caution On Tavneos Use

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 earlier this year. In March, the U.S. Food and Drug Administration (FDA) warned patients and healthcare providers about serious and sometimes fatal liver injuries tied to Tavneos, citing postmarketing data that point to new safety concerns beyond those identified in clinical trials. In April, the FDA’s drug review arm proposed withdrawing approval for Tavneos, citing concerns over data integrity, lack of proven effectiveness, and misleading statements in its application. The Center for Drug Evaluation and Research (CDER) said new information revealed that key data supporting Tavneos’ approval was manipulated. The agency found that unblinded study personnel altered endpoint results in the Phase 3 ADVOCATE trial, the sole study used to establish the drug’s effectiveness. According to Kissei, the agency cited newly identified information suggesting a lack of substantial evidence supporting the drug's effectiveness. The FDA also alleged that the original application submitted by ChemoCentryx included untrue statements involving material facts. European Agency Reviewing Phase 3 Trial Data Separately, the European Medicines Agency in January announced that its Committee for Medicinal Products for Human Use had launched a review linked to concerns surrounding the integrity of data from a Phase III clinical study involving the drug. Kissei said it is currently collecting detailed information from both the U.S. and Europe while coordinating with Japan's Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labor and Welfare. Although Tavneos remains approved in Japan, the company said its immediate priority is ensuring patient safety through updated guidance to healthcare providers. AMGN Price Action: Amgen shares were down 0.80% at $323.69 at the time of publication on Monday, according to Benzinga Pro data. Photo by JHVEPhoto via Shutterstock Read Also: Bitmine Buys 71,672 ETH, But Tom Lee Says Oil Is The 'The Biggest Headwind'