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ChemoCentryx Announces Approval in Japan of TAVNEOS™ (Avacopan) for the Treatment of ANCA-Associated Vasculitis
Approved for use in Japan in patients with microscopic polyangiitis and granulomatosis with polyangiitis SAN CARLOS, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE)
About this update from Chemocentryx Inc.
[{"type":"text","content":"Approved for use in Japan in patients with microscopic polyangiitis and granulomatosis with polyangiitis\nSAN CARLOS, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that Kissei Pharmaceutical Co., Ltd. has received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) to market TAVNEOS™ (avacopan), an orally administered selective complement 5a receptor inhibitor, in Japan for the treatment of patients with microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), the two main forms of anti-neutrophil cytoplasmic autoantibody-associated vasculitis also known as ANCA-associated vasculitis or ANCA vasculitis. ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan in markets outside of the U.S., and Vifor Pharma has granted Kissei Pharmaceutical Co., Ltd. an exclusive license to commercialize TAVNEOS™ (avacopan), in Japan. ANCA-associated vasculitis was officially designated an intractable disease by the MHLW. Intractable diseases are rare diseases for which no effective treatment exists but for which long-term treatment is required. Japan promotes research related to intractable diseases and financially supports patients with these diseases. “This marks the first ever approval by a regulatory agency of a novel medication discovered and developed by ChemoCentryx. We would like to thank Kissei and the MHLW for their time and tremendous efforts, which made this important milestone in the mission to bring relief to patients suffering from diseases with major unmet needs possible,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. In other countries, the PDUFA goal date for the Food and Drug Administration (FDA) decision on the Company’s amended NDA is October 7, 2021 and the regulatory decision in Europe following the European Medicines Agency (EMA) review is expected by the end of 2021. About TAVNEOS™ (avacopan)TAVNEOS (avacopan), approved by the Japanese Ministry of Health, Labor and Welfare for the treatment of microscopic polyangiitis and granulomatosis with polyangiitis (the two main forms of ANCA-associated vasculitis), is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-d...