NEJM retracts study supporting Amgen’s Tavneos amid FDA fight

 The New England Journal of Medicine has retracted the clinical trial publication behind Amgen’s rare disease drug Tavneos after two of the study’s authors requested the retraction over undisclosed changes to how patient outcomes were assessed. 

In a June 29 retraction statement, NEJM said the primary endpoint assessments for nine patients were readjudicated after the trial’s database was locked and unblinded, without the two authors’ knowledge, calling the omission “inconsistent with proper research conduct.”

The retraction is the latest setback in a months-long dispute between Amgen and the FDA over Tavneos, a treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis that Amgen acquired through its $3.7 billion purchase of ChemoCentryx in 2022. The FDA first asked Amgen to voluntarily withdraw the drug from the market in January, citing concerns over how ChemoCentryx had re-adjudicated efficacy data for nine of the 331 patients in the pivotal trial. Amgen declined the request on Feb. 3, saying it was not aware of issues with the underlying patient data and that its own review of clinical findings and real-world evidence continued to support the drug’s effectiveness.

In late March, the FDA tied 76 cases of drug-induced liver injury, including eight deaths, to Tavneos. The agency followed in April with a more serious allegation, saying unblinded study personnel had manipulated the pivotal trial’s results so the drug appeared effective when the original analysis did not support that conclusion, a finding the FDA said it didn’t learn of until more than three years after approval. The agency said it could no longer conclude Tavneos had ever been proven effective.

Amgen has continued to defend the drug, saying patient safety guides every decision the company makes and that it remains confident in Tavneos’s safety and efficacy profile. The company requested a hearing with the FDA June 11 and enlisted the Duke Clinical Research Institute to conduct an independent, fully blinded re-adjudication of the data underlying the drug’s original approval.

https://www.beckershospitalreview.com/pharmacy/nejm-retracts-study-supporting-amgens-tavneos-amid-fda-fight/