The FDA has linked Amgen’s vasculitis drug Tavneos to 76 postmarketing cases of drug-induced liver injury, including eight deaths, 54 hospitalizations and 74 serious outcomes. Seven patients developed vanishing bile duct syndrome, three of whom died.
The medication, approved in October 2021, is used to treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. Most cases showed a cholestatic or mixed pattern of liver injury, with symptoms typically appearing within 46 days of treatment initiation, according to a March 31 FDA drug safety communication.
The update follows a Jan. 16 request from the FDA for Amgen to voluntarily withdraw Tavneos from the U.S. market. The agency cited concerns about hepatotoxicity and irregularities in ChemoCentryx’s handling of primary endpoint data in the pivotal trial. ChemoCentryx was acquired by Amgen in 2022.
Amgen declined the request and told Becker’s April 1 it continues to support Tavneos’ benefit-risk profile. “Patient safety always comes first, and we are in regular communication with the FDA about the safety of our medicines,” a spokesperson said. The company noted that liver toxicity is already addressed in the U.S. label and that it proactively submitted a proposed label update in 2024 to include vanishing bile duct syndrome, which remains under FDA review.
The FDA is advising clinicians to conduct regular liver function monitoring and consider discontinuing treatment if abnormalities or symptoms arise.
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