UK Regulator Suspends Amgen's Tavneos for New Patients Citing Unreliable Trial Data

The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use and sale of Amgen's rare-disease drug Tavneos for new patients, citing unreliable data from the primary study that supported its approval.

Regulatory Action and Rationale

The British regulator announced on Tuesday that due to the unreliable trial data, the study could no longer sufficiently demonstrate the drug's effectiveness or prove that its benefits outweighed its potential risks. Tavneos, also known as avacopan, is prescribed to treat severe autoimmune diseases that cause inflammation in small blood vessels.

The agency plans to fully revoke the drug's U.K. approval on March 1, 2027. For now, patients currently receiving Tavneos can continue their treatment for six months while their doctors evaluate alternative therapies. The MHRA has advised patients not to stop their treatment without first consulting a specialist.

Company Response and Context

Amgen (NASDAQ:AMGN) pushed back against the regulator's findings. "We disagree with the MHRA’s decision to withdraw Tavneos from the UK market and are deeply concerned about the impact this decision may have on rare-disease patients," an Amgen spokesperson told Reuters.

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The company stated that the regulator did not give adequate consideration to other supporting evidence, including data from other clinical trials and more than 20 real-world studies. Amgen acquired Tavneos through its $3.7 billion purchase of the drug's developer, ChemoCentryx, in 2022. While Amgen holds U.S. rights, CSL Vifor manages commercial rights in the U.K. and other select markets.

Broader European Scrutiny

This action by the U.K. regulator follows a similar move in Europe. In August, the European Commission revoked the marketing authorization for Tavneos after its own regulators concluded that key trial data was unreliable.

This series of regulatory setbacks raises significant questions about the future of the drug in European markets, a key asset from Amgen's recent multi-billion dollar acquisition.