Medicine & healthcare

Medical Journal Retracts Tavneos Study Over Data Concerns

Is this a justified public health safeguard or a devastating blow to patients with no alternative treatment?

Published JUN 30

#Medicine & healthcare

Medical Journal Retracts Tavneos Study Over Data Concerns

Story

Above: The Amgen office building in San Francisco, California, on Oct. 16, 2025. Image credit: Smith Collection/Gado/Getty Images

The Facts

The New England Journal of Medicine (NEJM) retracted a 2021 study supporting the approval of Amgen's Tavneos on Monday, over concerns regarding the credibility of the paper's data and results.
NEJM
Reuters
Bloomberg
A notice published in the NEJM stated that the study's two academic authors requested that it be pulled after a Food and Drug Administration (FDA) investigation found that primary endpoint data were readjudicated after database lock and trial unblinding.
NEJM
The NEJM notice added that the changes — which it described as "inconsistent with proper research conduct" — were not disclosed in the original article and were made without the knowledge of the authors.
NEJM
It follows a proposal by the FDA's Center for Drug Evaluation and Research to withdraw Tavneos from the market in April, citing a lack of substantial evidence of effectiveness and untrue statements of material fact in the original approval application submitted by ChemoCentryx, an Amgen subsidiary.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Last week, the EU's European Medicines Agency (EMA) followed suit after its human medicines committee (CHMP) concluded that the Advocate study was conducted in breach of good clinical practice principles, with study data found to be incorrect and misleading.
European Medicines Agency (EMA)
European Medicines Agency (EMA)
To defend the drug, Amgen engaged the Duke Clinical Research Institute in February to independently review data from the phase 3 Advocate study, with findings to be submitted to the FDA by July 29 as part of a hearing request to keep Tavneos on the market.
Fierce Pharma
BioSpace
U.S. Food and Drug Administration

Sources Split

LEFT

CENTER

RIGHT

ESTAB
CRIT

CENTER

PRO
ESTAB

The Spin

Narrative A

The move to pull Tavneos is fully justified, given that unblinded study personnel manipulated pivotal clinical trial results to make the drug appear effective, when the original analysis showed otherwise. This trickery is completely at odds with good medical science and puts patients at risk, necessitating the drug's removal from the market to safeguard public health.

European Medicines Agency (EMA)

U.S. Food and Drug Administration

Narrative B

Pulling Tavneos ignores years of real-world evidence showing that the drug supports remission, reduces relapse risk and cuts harmful glucocorticoid exposure for people with a devastating, life-threatening disease. As the only FDA-approved targeted oral treatment for severe active GPA and MPA, removing it would leave patients with no comparable alternative, to their detriment.