FDA Proposes Withdrawing Amgen's Tavneos Over Lack of Effectiveness
The US Food and Drug Administration has proposed withdrawing approval for Amgen's Tavneos, a drug for rare autoimmune diseases, saying new evidence shows it has not demonstrated effectiveness for its approved use.
The proposal came from the FDA's Center for Drug Evaluation and Research. Tavneos will remain available unless the manufacturer removes it or the FDA commissioner mandates its withdrawal. Tavneos was approved in October 2021 for adults with severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis, alongside standard-of-care treatment.
From the sources (4 posts)
@firstsquawkThe FDA’s Center for Drug Evaluation and Research (CDER) has proposed pulling approval for Tavneos.
@firstsquawkThe FDA stated that new evidence shows Tavneos has not demonstrated effectiveness for its approved use.
@firstsquawkAccording to the FDA, Tavneos will remain available until either the manufacturer removes it or the FDA commissioner mandates its withdrawal.
@reutersFDA proposes to withdraw Amgen's drug for rare autoimmune diseases over effectiveness