Approved for use in Japan in patients with microscopic polyangiitis and granulomatosis with polyangiitis
SAN CARLOS, Calif., September 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), a selective oral 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-vasculitis associated with neutrophilic cytoplasmic autoantibodies also known as ANCA-associated vasculitis or ANCA vasculitis.
ChemoCentryx’s Kidney Health Alliance with Vifor Pharma grants Vifor Pharma exclusive rights to market avacopan in markets outside the United States, and Vifor Pharma has granted Kissei Pharmaceutical Co., Ltd. an exclusive license to market TAVNEOS ™ (avacopan), in Japan.
Vasculitis associated with ANCA has been officially designated as an incurable disease by MHLW. Incurable diseases are rare diseases for which no effective treatment exists but for which long-term treatment is necessary. Japan encourages research related to incurable diseases and financially supports patients with these diseases.
“This is the first-ever regulatory body approval of a new drug discovered and developed by ChemoCentryx. We would like to thank Kissei and the MHLW for their tremendous time and effort, which made possible this important milestone in the mission of bringing relief to patients with major unmet need, ”said Thomas J. Schall, Ph.D., President and CEO of ChemoCentryx.
In other countries, the PDUFA deadline 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 review of the European Medicines Agency (EMA) is expected by the end of 2021..
On TAVNEOS ™ (avacopane)
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 vasculitis associated with ANCA), is a small medicine first class, administered orally. molecule that utilizes a novel, highly targeted mode of action in complement-induced autoimmune and inflammatory diseases. By precisely blocking the receptor (C5aR) of the fragment of the pro-inflammatory complement system known as C5a on destructive inflammatory cells such as blood neutrophils, avacopan stops the ability of these cells to damage in response to l activation of C5a, which is known to be the engine of vasculitis associated with ANCA. Current therapies for ANCA-associated vasculitis and other associated diseases generally include extensive immunosuppression with daily doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which can cause significant illness and even death. Selective inhibition by TAVNEOS of C5aR alone leaves the beneficial C5a pathway via the normally functioning C5L2 receptor.
ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and lupus nephritis (LN). The United States Food and Drug Administration has granted orphan drug designation avacopan for vasculitis associated with ANCA and C3G. The European Commission has granted orphan drug designation to avacopan for the treatment of two forms of vasculitis associated with ANCA: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as C3G.
About vasculitis associated with ANCAs
ANCA-associated vasculitis is a systemic disease in which overactivation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This leads to organ damage and failure, with the kidney being the primary target, and is fatal if left untreated. Currently, treatment of ANCA-associated vasculitis consists of courses of non-specific immunosuppressants (cyclophosphamide or rituximab), combined with daily administration of glucocorticoids (steroids) for prolonged periods, which may be associated with significant clinical risk. up to death. of infection.
ChemoCentryx is a biopharmaceutical company developing new drugs for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets chemokine and chemotactic systems to discover, develop and commercialize orally administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), has successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and is in advanced clinical development for the treatment of severe HS and C3 glomerulopathy (C3G). ChemoCentryx also has early stage drug candidates that target chemotactic receptors in other inflammatory and autoimmune diseases and in cancer.
ChemoCentryx cautions that statements included in this press release that are not descriptions of historical fact are forward-looking statements. Words such as “may”, “could”, “will”, “should”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “have”. ‘Intent to’, ‘predict,’ ‘seek’, ‘consider’, ‘possible’, ‘continue’ or ‘plan’ or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s statements regarding the achievement of intended goals and milestones, including whether and timing of TAVNEOS (avacopan) will be approved for the treatment of patients with ANCA-associated vasculitis associated with ANCAs by the FDA and EMA. approvals, if applicable. The inclusion of forward-looking statements should not be construed as a representation by ChemoCentryx that any of its plans will be realized. Actual results may differ from those presented in this press release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the documents filed by the Company with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx assumes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s annual report on Form 10-K filed with the SEC. SEC on March 1, 2021 and its other reports available. on the SEC website (www.sec.gov) and on the ChemoCentryx website (www.chemocentryx.com) under “Investors”. All forward-looking statements are qualified in their entirety by this cautionary statement. This warning is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Susan M. Kanaya
Executive Vice President,
Financial and Administrative Director
Burns McClellan, Inc.