FDA Says Amgen's Tavneos Linked to Liver Injuries, Deaths — Update

By Elias Schisgall

The Food and Drug Administration said Tavneos, an Amgen drug used to treat a group of rare diseases that cause blood vessel inflammation, has been linked to dozens of cases of serious liver injuries, including eight deaths.

The FDA said it has identified 76 cases of drug-induced liver injuries with reasonable evidence of being causally linked to Tavneos. Of those, 74 cases reported serious outcomes, including eight deaths and 54 hospitalizations.

Some cases involved vanishing bile duct syndrome, a liver condition characterized by the progressive destruction of bile ducts in the liver, the agency said.

Most of the cases were reported in Japan, with a handful from the U.S., Europe, and Canada.

The cases "represent new safety concerns" around Tavneos, known generically as avacopan, the FDA said, adding that it continues to monitor post-marketing cases of DILI and VBDS involving the drug.

Amgen said it continues to monitor side effects related to Tavneos and regularly communicates with the FDA about patient safety, adding that it asked the agency to add VBDS to the Tavneos label in 2024. It said that request is still pending.

"We remain confident that TAVNEOS is an important and effective medicine for severe ANCA-associated vasculitis based on robust clinical data and real-world evidence demonstrating the effectiveness and favorable benefit-risk profile," an Amgen spokesperson said.

The FDA had asked Amgen to pull Tavneos from the U.S. market in January, citing some methodological concerns about a previous clinical trial and the risk of hepatotoxicity--a serious adverse reaction already described in Tavneos product labeling.

Amgen refused that request, saying that the drug's benefit-risk profile remained favorable. The company said Tuesday that it is evaluating a path forward for Tavneos with the FDA.

The FDA said Tuesday that the cases of DILI and VBDS represent new risks for patients. It advised patients to conduct regular liver panel testing when first taking the treatment.

Tavneos was developed by the biotechnology company ChemoCentryx, which Amgen acquired for $3.7 billion in cash in 2022. At the time, Tavneos was the ChemoCentryx's only approved drug, and Amgen said it was excited to assist in the launch.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

March 31, 2026 11:32 ET (15:32 GMT)