Benzinga | Nov 12, 2021 08:42AM EST

ChemoCentryx Announces Positive Recommendation For Use Of TAVNEOS In ANCA Vasculitis Adopted By European Medicines Agency Committee For Medicinal Products For Human Use

ChemoCentryx, Inc., (NASDAQ:CCXI), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for the Company's TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, in combination with a rituximab or cyclophosphamide regimen, indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

"The CHMP recommendation to authorize TAVNEOS represents a positive step toward our goal of making TAVNEOS available in key markets throughout the world," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "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."

Following the CHMP's positive opinion, the European Commission will render an official decision as to the authorization of the use of TAVNEOS in the European Union in January 2022.

Under the terms of the Company's Kidney Health Alliance with Vifor Pharma, Vifor Pharma has exclusive rights to commercialize TAVNEOS in countries outside of the United States. Vifor Pharma has granted Kissei Pharmaceutical Co., Ltd. an exclusive license to commercialize TAVNEOS (avacopan), in Japan, where TAVNEOS was approved for use in ANCA vasculitis patients in September. Vifor Pharma will pay ChemoCentryx royalties in the teens to the mid-twenties percent on potential ex-US net sales off one aggregate net sales line.

In the United States, TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.