Amgen's Tavneos Pulled by EU Over Study Breaches

Amgen's rare disease treatment Tavneos has come under intense scrutiny after European regulators pulled its marketing authorization, citing 'serious breaches' in a pivotal study.

The study found that patients who had previously been deemed non-responsive to the treatment suddenly began responding, and researchers re-adjudicated their data based on this new information.

Regulators were unable to isolate the impact of these changes, leading them to conclude that the study as a whole was unreliable and results provided at the time of application 'incorrect and misleading'.

Tavneos, approved in 2021 for certain forms of ANCA-associated vasculitis, is also under scrutiny from the FDA, which has asked Amgen to voluntarily pull the drug from the market.

Despite this, Amgen continues to defend Tavneos, citing growing sales and a robust defense with real-world evidence to support its benefit-risk profile.