▎WuXi AppTec Content Team ReportToday(November 5), the official website of China's National Medical Products Administration (NMPA) announced，ACategory 5.1 New DrugAvacopan Hard CapsulesThe marketing application has been approved.Public information shows that avacopan is aOrally Administered Selective Complement C5a Receptor (C5aR) Inhibitor, has been approved for treatment in multiple countries worldwideAnti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis. The drug was also selectedThe "Star" Small Molecules of 2022 Published on DrugHunter.comList。ANCA-associated vasculitis is a group of rare vascular inflammatory diseases that may lead to organ dysfunction. The disease mechanism isDue to the overactivation of the C5a complement pathway, further activating neutrophils, leading toSystemic Inflammatory ResponseAnd small vessel destruction, leading toMay cause severe damage and dysfunction in the kidneys, lungs, and other organs.The treatment of ANCA-associated vasculitis includes non-specific immunosuppressants (cyclophosphamide or rituximab) combined with long-term daily administration of glucocorticoids, which may lead to significant clinical risks, including death caused by infection.AvacopanIt is an orally administered selective complement 5a (C5a) receptor inhibitor, whichBy precisely blocking the C5a receptor located on inflammatory cells such as neutrophils, these cells are prevented from being activated by C5a, reducing inflammatory damage.。
September 2021,Avacopan ObtainedJapanese Ministry of Health, Labour and Welfare (MHLW)Approval，For the treatment of two major anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitides: Microscopic Polyangiitis (MPA) and Granulomatosis with Polyangiitis (GPA).In October 2021, the drug was again approved by the FDAApproval, in combination with standard therapy, as an adjunctive treatment for two major types of anti-neutrophil cytoplasmic antibody-associated vasculitis, namely MPA and GPA.According toChemoCentryxEarlier press release from the company,This is the first FDA-approved ANCA-associated vasculitis drug in a decade, and also the first orally-administered complement C5a receptor inhibitor approved by the FDA.
Publicly available information shows,The relevant rights of Avacopan involve multiple global licensing collaborations and company acquisitions. The product was initiallyDiscovered and developed by ChemoCentryx, Inc., which holds commercialization rights in the United States.。The commercial rights for Avacopan in markets outside the United States are owned by CSL Vifor (a company under CSL, a well-known Australian pharmaceutical enterprise).In August 2022, Amgen announced an investment of approximately $3.7 billion.AcquisitionChemoCentryx, Inc., thereby acquiring partial rights to the product; 22023In July, Amgen announced once again that it had reached an agreement with CSL Vifor.Agreement，Obtain the commercial rights of Avacopan in Asia and Latin America, including the Chinese mainland market.。This means that,Amgen will also have the commercial rights to Avacopan in Asia and Latin America, including the Chinese mainland market.Avacopan's approval in Japan and the United States is based onPositive results from a pivotal Phase 3 trial support.According to earlierPublished in"The New England Journal of Medicine" (NEJM）Clinical trial data,Data from 331 patients with polyangiitis and granulomatosis with polyangiitis indicate that, according to the Birmingham Vasculitis Activity Score (BVAS), at week 52 of treatment,AvacopanThe remission rate of the group was better than that of standard treatment.。Specifically, at Week 52 of treatment,AvacopanGroup65.7% of patients observed sustained relief, the control drug group was 54.9%.In terms of safety, 37.3% acceptedAvacopanSevere adverse events (excluding vasculitis worsening) occurred in 39.0% of patients receiving the control drug.In China,AvacopanHard capsules have previously received an implied permission for clinical trials, with the indication being: treatment of adult patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis).
Hope AvacopanHard capsules arrive to patients sooner, making the drugBenefit more patients.[1]Information on the Delivery of Drug Approval Documents on November 5, 2024. Retrieved Nov 05，2024. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241105145400132.html[2] VFMCRP announces approval for Tavneos® (avacopan) for the treatment of ANCA-associated vasculitis in Japan. Retrieved September 27, 2021, from https://www.businesswire.com/news/home/20210926005078/en/[3] ChemoCentryx Announces FDA Approval of Tavneos™(avacopan) in ANCA-Associated Vasculitis. Retrieved October 8, 2021, from https://www.globenewswire.com/news-release/2021/10/08/2311086/19219/en/ChemoCentryx-Announces-FDA-Approval-of-Tavneos-avacopan-in-ANCA-Associated-Vasculitis.html[4] Avacopan for the Treatment of ANCA-Associated Vasculitis. (2021). New England Journal of Medicine, 384(21), e81. https://doi.org/10.1056/nejmc2104672
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