Otsuka Canada Pharmaceutical Inc. announces Health Canada approval of TAVNEOS® (avacopan) for ANCA-Associated Vasculitis
- Health Canada approved the first orally-administered inhibitor of the complement 5a receptor – for the treatment of two types of ANCA-associated vasculitis (GPA and MPA), a debilitating disease with significant unmet medical needs
- Launch is expected in Canada in the fourth quarter of 2022
MONTREAL, April 20, 2022 /CNW Telbec/ - Otsuka Canada Pharmaceutical Inc. (OCPI) today announced that Health Canada has approved Tavneos® (avacopan), an orally administered selective complement 5a receptor inhibitor, for the 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 background therapy including glucocorticoids1. ANCA-associated vasculitis is a debilitating, rare autoimmune systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as a major target, and is often fatal if not treated. ANCA-associated vasculitis affects an estimated 7,500 Canadians. 2, 3, 4
"On behalf of patients living with ANCA-associated vasculitis we are very happy with the approval of this life-changing treatment option." – Jon Stewart, President of Vasculitis Foundation Canada
"Avacopan has now proven to be a new and integral cornerstone treatment for the induction of remission in patients with GPA and MPA, in addition to rituximab or cyclophosphamide. It is the first medication of its kind to allow for a substantial reduction in the use of glucocorticoids and may also provide additional benefits in terms of renal recovery." – Dr. Christian Pagnoux, Rheumatologist, Toronto, Co-founder, and President of CANVASC
"We are very proud to be bringing this new treatment option to Canadian patients living with ANCA-associated vasculitis. The availability of avacopan, a first in class targeted treatment for ANCA-associated vasculitis, is highly anticipated in Canada as it represents an important advancement that will address clinical care gaps and extend remission." – Michael Laranjo, President, and General Manager of OCPI
The approval of Tavneos (avacopan) in ANCA-associated vasculitis was supported by the results of the pivotal Phase 3 ADVOCATE trial, published in the New England Journal of Medicine, which was conducted in a total of 330 patients in 20 countries, including Canada. The study met its primary endpoints of disease remission at week 26 and sustained remission at week 52, as assessed by the Birmingham Vasculitis Activity Score. Tavneos demonstrated superiority over standard of care at 52 weeks.5
"This targeted therapy will be available for patients living with ANCA-associated vasculitis in Canada. Results from the Phase 3 ADVOCATE trial demonstrate that treatment with avacopan is not only very effective but also helps to minimize side effects by enabling replacement of a more traditional component of ANCA-associated vasculitis treatment." – Dr. Louis-Philippe Girard, Nephrologist, Calgary
In April of 2021, OCPI secured exclusive rights from Vifor Fresenius Medical Care Renal Pharma to promote and distribute Tavneos (avacopan) in Canada. OCPI expects to launch Tavneos in Canada in the fourth quarter of 2022 upon supply availability. Tavneos, developed by ChemoCentryx, Inc., is also approved in the European Union, the United States and Japan.
Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing health care company that commercializes novel medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardio-renal, and nephrology. OCPI was established in 2010, with headquarters in Saint-Laurent, Quebec. OCPI is part of Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: "Otsuka – people creating new products for better health worldwide." Otsuka Pharmaceutical Co., Ltd., researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
Otsuka Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employs approximately 47,000 people worldwide and had consolidated sales of approximately USD 13.6 billion in 2021.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka on our global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Canada at www.otsukacanada.com.
Tavneos (avacopan) is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment, C5a on inflammatory cells such as blood neutrophils, Tavneos arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, Tavneos selective inhibition of only the C5aR1 leaves the beneficial C5a l pathway through the C5L2 receptor functioning normally. Tavneos was developed by ChemoCentryx Ltd. who is also developing Tavneos for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted Tavneos orphan drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome. The European Commission has granted orphan medicinal product designation for Tavneos for the treatment of two forms of ANCA-associated vasculitis: MPA and GPA (formerly known as Wegener's granulomatosis), as well as for C3G.
Tavneos is a registered trademark of ChemoCentryx used under license by Otsuka Canada Pharmaceutical Inc.
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as a major target and fatal if not treated. Treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose and often prolonged use of glucocorticoids, which can be associated with significant adverse events including death from infection. ANCA-associated vasculitis is a relapsing and remitting long-term condition and patients are at risk of cumulative organ damage8.
1. Product monograph April 14, 2022, Tavneos (avacopan) indication: The 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 background therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use.
2. Yates M, Watts RA, Bajema IM, et al. EULAR/ERA-EDTA recommendations for the management of ANCA-associated vasculitis. Ann Rheum Dis. Sep 2016;75(9):1583-94. doi:10.1136/annrheumdis-2016-209133
3. Berti A, Dejaco C. Update on the epidemiology, risk factors, and outcomes of systemic vasculitides. Best Practice & Research Clinical Rheumatology. Apr 2018;32(2):271-294. doi:10.1016/j.berh.2018.09.001
4. Anderson K, Klassen J, Stewart SA, Taylor-Gjevre RM. Does geographic location affect incidence of ANCA-associated renal vasculitis in northern Saskatchewan, Canada? Rheumatology (Oxford). Oct 2013;52(10):1840-4. doi:10.1093/rheumatology/ket226
5. Jayne DRW, Merkel PA, Schall TJ, Bekker P, ADVOCATE Study Group; Avacopan for the Treatment of ANCA-Associated Vasculitis; N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386.
6. Merkel PA, Niles J, Jimenez R, et al.; Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis; ACR Open Rheumatol. 2020 Nov;2(11):662-671. doi: 10.1002/acr2.11185.
7. Jayne DRW, Bruchfeld AN, Harper L, et al.; Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis; J Am Soc Nephrol. 2017 Sep;28(9):2756-2767. doi: 10.1681/ASN.2016111179.
8. Kitching AR, Anders HJ, Basu N, et al.; ANCA-associated vasculitis; Nat Rev Dis Primers. 2020 Aug 27;6(1):71. doi: 10.1038/s41572-020-0204-y.
SOURCE Otsuka Canada Pharmaceutical Inc.
Milena Bembic, Vice-President Legal Affairs and Compliance, 514-332-3175, [email protected]
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