FDA Warns of Liver Injury Cases Linked to Amgen's Tavneos

The U.S. Food and Drug Administration (FDA) has issued a warning regarding Amgen Inc.'s drug Tavneos, which is used to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare autoimmune disease. The FDA has identified 76 cases of drug-induced liver injury associated with Tavneos, including eight fatalities. Among these cases, seven were linked to vanishing bile duct syndrome (VBDS), a rare condition that can lead to permanent liver damage. The agency has urged healthcare providers to discontinue the drug if liver damage is suspected.

The Straits TimesBloomberg

In January 2024, the FDA requested that Amgen voluntarily withdraw Tavneos from the market due to concerns regarding the integrity of clinical trial data. Amgen declined this request, asserting confidence in the drug's benefit-risk profile and indicating that it was collaborating with the FDA on further steps. The company has proposed an update to Tavneos' labeling to include VBDS as an adverse reaction, a request that remains pending with the FDA.

The Straits Times

The European Medicines Agency (EMA) has also initiated a review of Tavneos following emerging concerns about the data integrity of the studies supporting its approval. While the drug's labeling in Europe and Australia includes warnings about VBDS, the U.S. prescribing information does not currently reflect this risk.

The Straits Times

The FDA's report highlights that the majority of serious drug-related injuries were reported from Japan, with five cases from the United States, four from Europe, and one from Canada. The agency continues to monitor the situation closely, as the safety concerns surrounding Tavneos have prompted increased regulatory scrutiny.

Bloomberg

Critics have raised concerns about the adequacy of the clinical research that supported Tavneos' approval, questioning the reliability of the data presented by Amgen. The FDA's findings and the subsequent warning have led to skepticism regarding the drug's safety profile, particularly in light of the deaths associated with its use.

Bloomberg

Amgen has stated that it remains confident in Tavneos as an important and effective treatment option. The company emphasized its commitment to addressing the FDA's concerns and updating the drug's labeling as necessary. An Amgen spokesperson noted that the company has not received feedback from the FDA regarding its proposed label update since November 2024.

Bloomberg

As the FDA and EMA continue their reviews, the future of Tavneos remains uncertain. Amgen's ongoing discussions with regulatory bodies will be critical in determining the drug's status in the market and any necessary changes to its labeling or usage guidelines.

Bloomberg

• “represent new safety concerns,” — FDA Statement

Bloomberg

• “confident that Tavneos is an important and effective medicine.” — Amgen Spokesperson

The Straits Times