FDA proposed to rescind the approval of Tavneos, Amgen’s oral treatment for ANCA-associated vasculitis, after CDER concluded that data from the drug’s pivotal trial was “manipulated” to support an efficacy finding the original analysis didn’t back.
CDER’s letter to Amgen and its subsidiary ChemoCentryx says the application contained untrue statements and that “CDER can no longer conclude that there is, or has ever been, a valid demonstration that Tavneos is effective for its approved use.” The agency is also increasingly concerned about safety: 76 cases of drug-induced liver injury were reported through October 2024, with nearly all resulting in serious outcomes, including 54 hospitalizations and eight deaths.
This isn’t Amgen’s first confrontation with FDA on Tavneos. Earlier this year, when FDA asked the company to voluntarily pull the drug, Amgen refused. The company now says it “remains confident in Tavneos as a safe and effective medicine” and that its “perspective on the benefit-risk profile differs from the Agency’s.”
The stakes are concrete. Tavneos generated $459 million in 2025, a 62% jump from the prior year. Amgen paid $3.7 billion to acquire ChemoCentryx in 2022. CDER says it became aware of the manipulation more than three years after the October 2021 approval. That means it’s now arguing the drug never should have been cleared.
Amgen’s options now: withdraw Tavneos voluntarily or request a formal hearing.
Sarah Chen