EMA panel recommends Tavneos withdrawal, hitting Amgen

Amgen (AMGN) faces a potential EU withdrawal of its rare-disease therapy Tavneos after an expert panel of the European Medicines Agency recommended the drug be pulled from the market.

The panel, the Pharmacovigilance Risk Assessment Committee, said the risks of Tavneos outweigh its benefits for treating ANCA-associated vasculitis. The recommendation follows a routine safety review, though the EMA has not disclosed specific data that triggered the reassessment. Tavneos, also known as avacopan, was approved in the EU in 2022 and is Amgen's only approved drug for the autoimmune condition in the region.

A full withdrawal would remove a modest but growing revenue stream. Tavneos generated about $200 million globally in 2024, with roughly a quarter of that coming from Europe. The drug is also approved in the U.S., where a similar review is not currently underway. Amgen acquired Tavneos through its $27.8 billion purchase of Horizon Therapeutics in 2023, making the therapy a key part of the rare-disease portfolio the deal was built around.

The recommendation now goes to the EMA's Committee for Medicinal Products for Human Use, which will adopt a final opinion within 60 to 90 days. The European Commission typically follows the CHMP decision. Amgen can request a re-examination or provide additional data before the final ruling.

Amgen carries an Alpha Score of 62 out of 100, labeled Moderate, reflecting balanced risk-reward in healthcare. The stock is down about 2% in premarket trading as investors assess the regulatory hit. The broader market has been mixed, with the S&P 500 flat on the session.

A final EMA decision is expected by mid-year. A withdrawal would narrow Amgen's rare-disease pipeline in Europe, though the company has several other approved therapies in the region, including Repatha and Prolia.