EU Committee Recommends Approval of Tavneos for Severe, Active AAV
A committee of the European Medicines Agency has recommended approving Tavneos (avacopan) as an add-on therapy for adults with severe, active microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA), the two most common types of ANCA-associated vasculitis.
This recommendation from the Committee for Medicinal Products for Human Use (CHMP) will be reviewed by the European Commission, which is expected to make a final decision early next year. The potential approval will cover all European Union member states, as well as Iceland, Liechtenstein, and Norway.
“We are very encouraged by the recommendation from the CHMP and we anticipate the final ratification by the European Commission in [the first quarter of] 2022,” Klaus Jensen, MD, chief medical officer at Vifor Pharma, said in a press release. The company holds rights to commercialize Tavneos outside the U.S. from original developer ChemoCentryx.
“There is an unmet need for additional therapeutic options for patients suffering from ANCA-associated vasculitis and the challenging side-effects of current standard of care,” Jensen said. “Tavneos can become the new standard for the treatment of this systemic and debilitating disease, with the potential to significantly help an underserved patient population lead better, healthier lives.”
Tavneos is an oral small molecule that works by blocking the activity of the complement system, a group of pro-inflammatory immunological proteins in the blood that defend the body from infectious agents. Over-activity of the complement system is believed to be a major driver of inflammation in ANCA-associated vasculitis.
The therapy was approved earlier this year as an add-on therapy for MPA and GPA in the U.S. and in Japan.
These approvals were supported by data from a Phase 3 clinical trial called ADVOCATE (NCT02994927), in which 331 people with MPA or GPA were randomly assigned to treatment with Tavneos or a standard regime of the glucocorticoid prednisone for about a year. All patients also received standard immune-suppressing medicines, rituximab or cyclophosphamide, followed by azathioprine.
Results showed that treatment with Tavneos was comparable to steroids at inducing clinical remission after six months (72.3% and 70.1%), but rates of sustained remission at one year were significantly higher with Tavneos (65.7% vs. 54.9%).
Additional data indicated that Tavneos was better at improving kidney function, particularly among individuals with advanced kidney disease at the start of the trial, and had less steroid-associated toxicity, consistent with more steroids being used in the prednisone group.
Common side effects associated with the treatment included nausea, headache, high blood pressure, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, prickling sensation, and an increase in levels of blood creatinine (a marker of kidney dysfunction).
“The CHMP recommendation to authorize Tavneos represents a positive step toward our goal of making Tavneos available in key markets throughout the world,” Thomas J. Schall, PhD, president and CEO of ChemoCentryx, said in a company press release.
“Following the recent regulatory approvals in the U.S. and Japan, we hope that patients in Europe suffering from this debilitating and deadly disease may soon have access to Tavneos,” he added.