EU regulators move to revoke authorization for vasculitis drug TAVNEOS

The decision targets TAVNEOS (avacopan), an oral medication used to treat adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis. These conditions, which fall under the category of ANCA-associated vasculitis, cause the immune system to damage blood vessels, often leading to severe organ failure. The European Commission must now finalize the recommendation, which would effectively halt the drug's use across the European Economic Area.

Dr. Bill Mezzanotte, Head of R&D at CSL, confirmed the company will respect the regulatory outcome while acknowledging the difficulty for patients who rely on the therapy. Vifor Fresenius Medical Care Renal Pharma and CSL are currently coordinating with healthcare providers to transition patients to alternative treatments. No new patients will be initiated on the drug, and those currently prescribed TAVNEOS are urged to consult their physicians immediately regarding the shift in their care plan.