The EMA moved to withdraw Amgen’s Tavneos (avacopan) from the market, and the U.K.’s MHRA is now joining the action. MHRA said it has removed Tavneos from use by new patients as of Sept. 1, while providing limited supply availability for existing vasculitis patients through a six-month transition period. The double-regulator step increases pressure on Amgen to clarify the basis for the withdrawal and on clinicians to transition patients to alternatives without interrupting vasculitis management. The decision also underscores how post-market scrutiny and evidence requirements can shift rapidly across jurisdictions for specialty immunology drugs.
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