EMA recommends revoking EU marketing authorization for TAVNEOS due to trial data concerns.

The European Medicines Agency's Committee has recommended revoking the EU marketing authorization for TAVNEOS, a treatment for severe ANCA-associated vasculitis, following concerns about data handling in a key clinical trial. If confirmed by the European Commission, TAVNEOS will no longer be authorized in the EU, and no new patients will start treatment. Current patients are advised to consult their doctors for alternative options. The decision impacts a drug that has been important for a rare, life-threatening disease with limited treatments.