UK advocates prepare for potential withdrawal of AAV therapy
EU regulators revoke marketing authorization for Tavneos
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Patient advocates are preparing for the potential withdrawal of Tavneos (avacopan) for ANCA-associated vasculitis (AAV) in the U.K. as regulators there and in the U.S. weigh whether to pull the plug on the therapy’s approval.
Authorities in the European Union have revoked market authorization for Tavneos following concerns about data manipulation in clinical trials.
The advocacy group Vasculitis UK said in a press release that it is “monitoring developments daily and preparing for all possible outcomes,” working with the U.K.’s publicly funded healthcare system to develop clinical guidelines on how to proceed if the country’s Medicines and Healthcare products Regulatory Agency (MHRA) decides to revoke Tavneos’ approval.
AAV is caused when certain immune cells become overactive, triggering inflammation in small blood vessels. Tavneos is designed to block the activity of the complement system, a group of immune proteins involved in inflammation. The therapy has been widely approved as an add-on treatment for the most common forms of AAV, microscopic polyangiitis (MPA), and granulomatosis with polyangiitis (GPA).
Approvals based on trial data
Tavneos approvals were based primarily on data from a Phase 3 trial, ADVOCATE (NCT02994927). The study enrolled more than 300 people with AAV, all of whom received standard immune-suppressing AAV treatment. Some patients were randomly assigned to add-on therapy with prednisone, a widely used corticosteroid. Other patients received add-on Tavneos instead.
Chemocentryx, the company that originally developed Tavneos, announced in 2019 that the trial had met its main goal, showing that remission rates were significantly higher in patients given add-on Tavneos. However, recent allegations suggest that the study did not actually meet its goal, and that data were misrepresented to make it appear to have done so.
According to a report from the European Medicines Agency (EMA), five patients given Tavneos had their response status changed after the trial ended to make it appear they had achieved remission, even though they hadn’t. In independent analyses, Tavneos was not significantly better than prednisone at inducing remission.
The EMA said the questions about data integrity mean the clinical trial results can no longer be relied upon, making it impossible to say if the benefits of Tavneos outweigh the therapy’s risks, which include the potential for liver damage. An EMA committee recommended revoking Tavneos’ approval, and the European Commission did so earlier this month.
Patients in Europe who have been receiving Tavneos should not discontinue treatment immediately, as doing so may be dangerous. However, patients are advised to discuss with their healthcare providers a plan to switch to a different treatment.
The U.K.’s MHRA is conducting its own review. The agency has held a meeting but has not yet issued its final verdict. In the U.S., an arm of the Food and Drug Administration (FDA) has recommended withdrawing Tavneos from the market, but the agency has not officially revoked approval. Amgen, which markets Tavneos in the U.S. after acquiring Chemocentryx, has declined a request from the FDA to voluntarily pull Tavneos from the market.
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