The New England Journal of Medicine retracted pivotal data for Amgen’s autoimmune drug, Tavneos. Two academic authors requested the retraction following an ongoing U.S. Food and Drug Administration (FDA) investigation. The probe suggests patient results were reevaluated after the trial was unblinded.
This development escalates a dispute between Amgen and the FDA. In January, the FDA asked Amgen to voluntarily withdraw Tavneos from the market. The agency cited concerns over data reliability and cases of liver injury.
Amgen continues to defend the drug's integrity. The retraction from the prestigious journal damages the product's credibility and may impact investor sentiment.