Positive CHMP recommendation for use of Tavneos in ANCA vasculitis.- ChemoCentryx, Inc.

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 2021. 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.