FDA
FDA proposes Tavneos market withdrawal
Clinical takeaway: Tavneos will remain available unless the manufacturer withdraws it or the FDA Commissioner orders removal. In the meantime, clinicians should discuss Tavneos and alternative treatment options with patients to help determine whether to start or continue therapy while the FDA completes its review of the drug’s marketing status.
On April 27, 2026, FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawing approval of Tavneos (avacopan). The oral therapy was approved in 2021 for adults with granulomatosis with polyangiitis and microscopic polyangiitis, to be used alongside glucocorticoids and other standard‑of‑care treatments.
According to CDER, new information obtained more than three years after approval showed that unblinded study personnel manipulated results from the pivotal clinical trial to make the drug appear effective when the original analysis didn't support that conclusion.
That original analysis was not disclosed to FDA, in violation of regulatory requirements. CDER now says it can no longer conclude there is, or ever has been, valid evidence supporting Tavneos’ effectiveness for its approved use and has issued a notice of opportunity for a hearing to the sponsor.
CDER also cited growing safety concerns, including postmarketing reports of serious drug‑induced liver injury and rare cases of vanishing bile duct syndrome, some with fatal outcomes.
Source: U.S. Food and Drug Administration. (2026, April 27). CDER proposes to withdraw approval of Tavneos