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June 6, 2022

Launch of TAVNEOS® Capsules 10mg, a selective Complement C5a Receptor Antagonist

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa, "Kissei") announced that TAVNEOS® Cap.10mg (general name: avacopan) will be launched on June 7, 2022 in Japan for the treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), two main types of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

TAVNEOS® is the first-in-class oral-administered agent available for the treatment of MPA and GPA by selectively blocking the complement C5a receptor. Kissei has gained the exclusive license to develop and commercialize TAVNEOS® in Japan from Vifor Fresenius Medical Care Renal Pharma Ltd. (Headquarter: Switzerland, CEO: Florian Jehle, "VFMCRP") in June 2017. Subsequently, Kissei joined the global phase III clinical trial (ADVOCATE trial) together with VFMCRP, which was sponsored by the originator, ChemoCentryx, Inc, (Headquarter: the U.S., CEO: Thomas J. Schall). TAVNEOS® has been granted orphan-drug designation by the Ministry of Health, Labor and Welfare in March 2019. Based on the successful results of the pivotal phase III ADVOCATE study, Kissei has submitted a marketing authorization application for the indication of MPA and GPA in February 2021 and received marketing authorization approval on September 2021 in Japan. This drug was listed on the NHI drug price list on May 25, 2022. Outside Japan, TAVNEOS® has been launched in the United States by ChemoCentryx, as well as in Germany and Austria by VFMCRP.

The goal of the treatment for MPA and GPA is induction of remission and sustaining remission and it's said that early suppression of inflammation and prevention or mitigation of relapse which causes organ damage and increase mortality risk are important in terms of improvement of long-term outcomes. As a standard of care for MPA and GPA, the combination therapy of high-dose glucocorticoid and immunosuppressant for induction of remission and the combination therapy of low-dose glucocorticoid and immunosuppressant for sustaining remission are recommended. However, the risk of severe side effects by glucocorticoid and immunosuppressant has been recognized as an issue. Based on the results of the ADVOCATE trial, TAVNEOS® is expected to be a new treatment option which leads to improved sustained remission, reduction in dose and the usage period of glucocorticoid, and reduction of relapse.

Kissei strives to further contribute to the treatment of MPA and GPA through distribution of TAVNEOS® and promotion.

The projected financial results for the fiscal year ending March 2023, which incorporates this progress, was disclosed at the time of the announcement of the financial results May 10, 2022.

《 TAVENEOS® reference 》
Brand Name: TAVNEOS® Cap. 10mg
General Name: Avacopan
Indications : Microscopic polyangiitis and Granulomatosis with polyangiitis
Dosage and Administration: The usual oral dosage for adults is 30mg of avacopan twice daily after breakfast and supper
NHI price : TAVNEOS® Cap. 10mg 1,403.90 JPY
Manufactured and Distributed by: Kissei Pharmaceutical Co., Ltd.
Date of Marketing Approval in Japan: September 27, 2021
Date of Drug Price Listing: May 25, 2022
Date of Launch in Japan: June 7, 2022



《 Reference 》

About ANCA (anti-neutrophil cytoplasmic auto-antibody)-associated vasculitis (AAV)
AAV is a rare and severe autoimmune disease characterized by no or very little immune complex deposition, necrotizing inflammation of the small blood vessels, and high ANCA-positive rates. It damages various organs, including the kidneys, lungs, and nervous system. The number of patients with AAV in Japan is estimated to be over 10,000 (based on the number of recipients of the certificates for special disease treatment for the designated intractable disease as of the end of fiscal 2020). The current standard of care focuses on glucocorticoids. Even though glucocorticoids show efficacy for AAV, there are clinical risks for example a high frequency of adverse events*.


* The New England Journal of Medicine, 2021, 384(7), 664


About TAVNEOS® Capsules 10mg (general name: avacopan)
TAVNEOS® (avacopan), an orally-administered small-molecule agent for the treatment of rare kidney diseases, has been developed by ChemoCentryx. TAVNEOS® inhibits C5a receptor in leukocytes, including neutrophils, and exhibits anti-inflammatory properties by preventing the migration of leukocytes as well as the expression and induction of adhesion molecules. MPA and GPA, the indications of TAVNEOS®, are classified as AAV. MPA and GPA are severe autoimmune diseases designated as an intractable disease by the Ministry of Health, Labour and Welfare in Japan. The number of patients with ANCA-associated vasculitis has been increasing rapidly in recent years, and in many cases, they present necrotizing glomerulonephritis. As a result of the ADVOCATE study, TAVNEOS® treatment for AAV is expected to demonstrate efficacy and reduce the risk of adverse events in the current standard of care.
ChemoCentryx has granted VFMCRP the exclusive license for TAVNEOS® in all countries outside the United States. VFMCRP has sublicensed the rights of TAVNEOS® to Kissei in Japan.

About the ADVOCATE study
ADVOCATE is a double-blind controlled global phase III study in 331 patients with MPA and GPA in 20 countries and regions, including Japan. In this study, Avacopan has demonstrated non-inferiority to the steroid treatment in remission of vasculitic symptoms at Week 26 and superiority to the steroid treatment in sustained remission at Week 52 as assessed by the primary endpoint of Birmingham Vasculitis Activity Score (BVAS). Avacopan also showed better tolerability compared to the steroid treatment.
The result of ADVOCATE study was published in New England Journal of Medicine on February 18, 2021*.


* David R.W. Jayne, M.D., Peter A. Merkel, M.D., M.P.H., Thomas J. Schall, Ph.D., and Pirow Bekker, M.D, Ph.D. for the ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis
The New England Journal of Medicine, 2021, 384(7), 599 
https://www.nejm.org/doi/full/10.1056/NEJMoa2023386


About Complement C5a receptor
Complement is a system of proteins found in blood and associated with various immune responses and preventing infection. There are many kinds of complements, generally expressed as C by taking the initial letter of complement. C5a is one of components and acts as a chemotactic factor, attracting neutrophils to the inflamed area. TAVNEOS® is thought to exhibit anti-inflammatory properties by inhibiting the C5a receptor, thereby suppressing excessive activity of neutrophils that damages blood vessels.

About Vifor Fresenius Medical Care Renal Pharma (VFMCRP)
VFMCRP belongs to the Vifor Pharma Group and is a joint venture of Vifor Pharma Group and Fresenius Medical Care. VFMCRP has developed and commercialized innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease (CKD) worldwide. VFMCRP has also granted Kissei the license for sucroferric oxyhydroxide product which is marketed as Velphoro® in Europe and P-TOL® in Japan for the treatment of hyperphosphatemia. Vifor Pharma Group is a global pharmaceutical company. It aims to become the global leader in iron deficiency and nephrology. Vifor Pharma Group is headquartered in Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

About ChemoCentryx, Inc.
ChemoCentryx is a biopharmaceutical company developing new oral medications targeted at inflammatory, autoimmune diseases and cancer. ChemoCentryx is headquarted in the United States and listed on NASDAQ (NASDAQ: CCXI). TAVNEOS® is an agent discovered by ChemoCentryx.