Europe’s medicines regulator moves to revoke Amgen’s Tavneos approval

Europe’s medicines regulator moved to revoke Amgen’s Tavneos approval on June 26 after concluding that the evidence behind the drug raised integrity concerns, not just routine questions about paperwork or follow-up. The Committee for Medicinal Products for Human Use recommended that no new patients begin Tavneos and that people already taking it be switched to suitable alternatives.

The drug, sold as Tavneos and known generically as avacopan, is used for ANCA-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis. The European Medicines Agency said the case was handled under an Article 20 non-pharmacovigilance referral, a formal process that allows the agency to revisit a medicine’s benefit-risk balance and ask stakeholders to submit data as needed.

That makes the decision especially consequential for a rare-disease therapy that had already cleared a high bar. At approval, the EMA said Tavneos had been found at least as effective as a 20-week course of high-dose corticosteroids for inducing remission and to have produced better 52-week remission rates than the comparator. The new review cuts directly against that earlier assessment by questioning whether the trial record supporting those findings remains reliable.

The European move now sits alongside pressure from both sides of the Atlantic. In April, the FDA’s Center for Drug Evaluation and Research proposed withdrawing Tavneos approval after identifying 76 cases of drug-induced liver injury. Amgen’s deadline for submitting data to the FDA has since been extended to July 29 from June 29, giving the company more time to make its case while prolonging uncertainty for doctors, patients and investors.

The United Kingdom has also opened its own review. On June 5, the UK Medicines and Healthcare products Regulatory Agency said it was examining the benefits and risks of avacopan after questions were raised about the integrity and reliability of pivotal clinical study data. The European action adds weight to those concerns and increases the chances that regulators in other markets will keep pressing for a fuller accounting of how the evidence was generated.

A June 26 company announcement from Vifor Fresenius Medical Care Renal Pharma, the European licensee, said patients currently on Tavneos should consult their treating physician. For Amgen, the issue now extends beyond one specialty product’s sales: the company must persuade regulators that the data underpinning a complex rare-disease drug can still support continued use in Europe, the United States and beyond.