European Regulators Advise Revoking Authorization for Amgen's Tavneos
The European Medicines Agency (EMA) has recommended withdrawing the marketing authorization for Amgen's drug Tavneos, used for severe granulomatosis with polyangiitis or microscopic polyangiitis. This decision follows concerns about data integrity in the primary study supporting its approval, suggesting the drug's benefits are no longer considered to outweigh its risks. New patients are advised against starting Tavneos, and current users should transition to alternative treatments.
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