Amgen's Rare-Disease Asset Tavneos Faces Global Regulatory Backlash

Amgen is facing a significant setback in its rare-disease treatment, Tavneos (avacopan), after UK regulators suspended new patient use and set a path towards full withdrawal by March 2027. This decision follows similar actions in Europe and a proposed US withdrawal.

Tavneos treats severe forms of ANCA-associated vasculitis, rare autoimmune diseases that can damage organs such as the kidneys and lungs. Amgen acquired Tavneos through its $3.7 billion purchase of ChemoCentryx in 2022.

The UK Medicines and Healthcare Products Regulatory Agency cited concerns about the reliability of efficacy data from a pivotal study, leading to the suspension of new patient use as of September 1. Existing patients have six months before authorization is revoked on March 1, 2027.

Amgen's spokesperson expressed disagreement with the decision, highlighting its impact on rare-disease patients.