Postmarketing data has linked serious cases of drug-induced liver injury (DILI) to Amgen's approved oral complement 5a inhibitor, Taveneos (avacopan), leading the FDA to reiterate its request that Amgen voluntarily withdraw the drug.
According to the FDA, there is "reasonable evidence of a causal association" between Taveneos use and liver injury. A total of 76 patients have suffered DILI, including 54 hospitalizations and eight deaths. In three of the fatal cases, the patients developed vanishing bile duct syndrome (VBDS), a condition that may result in permanent liver damage.
Taveneos is an oral complement 5a inhibitor that treats active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. It received approval in 2021 as an adjunctive treatment, with patients typically taking the drug alongside glucocorticoids. Premarket clinical trials revealed a risk of hepatotoxicity, but the cases of VBDS and fatal DILI have revealed new safety risks.
Amgen says it has no intention of withdrawing the medication from the market. The FDA advises physicians who have patients taking the drug to carry out regular liver panel testing to check for symptomatic cholestasis and abnormally high levels of alanine aminotransferase or aspartate aminotransferase.