The FDA’s Center for Drug Evaluation and Research has proposed withdrawing approval of Tavneos (avacopan) after determining the drug has not been shown to be effective for its approved use.
The agency said new information revealed unblinded study personnel manipulated results of the pivotal clinical trial to make the drug appear effective and that the original analysis was not disclosed to the FDA, according to an April 27 agency statement.
CDER also cited safety concerns, including cases of drug-induced liver injury and vanishing bile duct syndrome, some with fatal outcomes, as detailed in a March 31, 2026, safety communication.
The proposal follows earlier FDA scrutiny of the drug. The agency has linked Tavneos to 76 postmarketing cases of drug-induced liver injury, including eight deaths, 54 hospitalizations and 74 serious outcomes.
In January, the FDA asked Amgen to voluntarily withdraw the drug from the market. Amgen declined, saying it supports the drug’s benefit-risk profile.
“We remain confident in Tavneos as a safe and effective medicine, supported by years of clinical data and real-world evidence,” Amgen said in a statement to Becker’s. “Our perspective on the benefit-risk profile of Tavneos differs from the Agency’s. We will evaluate next steps and respond to the FDA, while keeping patient needs and support at the forefront.”
The drug will remain on the market pending a final decision, which could include a hearing and determination by the FDA commissioner on whether to withdraw approval.
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