FDA Proposes Revoking Approval of Amgen's Tavneos

U.S. Food and Drug Administration's Center for Drug Evaluation and Research proposed withdrawing approval of Amgen's drug Tavneos on April 28, 2026. The proposal cites a lack of proven effectiveness and false statements in the original application for Tavneos.

A senior official at the CDER sent a letter to Amgen on April 27, 2026, stating that the agency can no longer conclude that there is or has ever been a valid demonstration of substantial evidence of effectiveness for Tavneos. In March 2026, the FDA identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos.

Among the 76 cases of drug-induced liver injury linked to Tavneos, there were seven cases of vanishing bile duct syndrome.

Vanishing bile duct syndrome is a rare condition that can cause permanent liver damage. The CDER letter proposed withdrawing Tavneos because of new information withheld from the FDA, which did not become known until more than three years after approval, indicating a lack of substantial evidence of effectiveness and untrue statements of material facts in the application.

Amgen did not immediately respond to a Reuters request for comment on April 28, 2026. Tavneos was approved by the FDA in October 2021. Tavneos treats anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

ANCA-associated vasculitis is a rare group of autoimmune diseases that cause inflammation in small- to medium-sized blood vessels. The FDA had previously asked Amgen to voluntarily withdraw the drug from the U.S. market amid concerns about trial data. Amgen declined the FDA's request to voluntarily withdraw Tavneos.

Amgen stated it was not aware of any problems with the underlying patient data, remained confident in Tavneos' benefit-risk profile, and was working with the FDA on next steps. Tavneos will remain on the market unless Amgen withdraws it or the FDA commissioner orders its removal.

The FDA advised healthcare professionals to discuss Tavneos and alternative treatment options with patients while a final decision on the drug's marketing status is pending.