Tavneos® (avacopan) recommended by England’s NICE for the treatment of AAV (GPA/MPA)
Vifor Fresenius Medical Care Renal Pharma announces that NICE has recommended Tavneos® for treating severe granulomatosis polyangiitis (GPA) and microscopic polyangiitis (MPA) in adults in England, Wales, and Northern Ireland. This oral therapy follows MHRA authorization in May 2022. Clinical trials showed Tavneos® met primary endpoints, offering a new treatment option with a favorable safety profile. The launch is expected shortly, marking a significant advancement in addressing the unmet medical needs of AAV patients.
- NICE's recommendation for Tavneos® provides a new treatment option for GPA/MPA patients.
- Approval based on pivotal phase-III trial results showing non-inferiority and superiority over prednisolone.
- The launch of Tavneos® is expected soon, indicating timely access for patients.
- None.
With this recommendation, eligible patients in
Launch of Tavneos® in the
“ANCA-associated vasculitis is a rare, systemic disease which can be rapidly fatal if not appropriately & promptly treated. The variable nature of the disease and its course along with challenging side-effects of current treatment options can severely affect subsequent quality of life for patients,” said
“NICE’s decision represents a major advancement for the treatment of GPA/MPA in the UK,” said Prof.
“We are delighted about this recommendation for patients in
MHRA approval and the NICE recommendation were based on findings from a comprehensive development program, culminating in the results from the pivotal phase-III trial (ADVOCATE) in 331 patients with ANCA-associated vasculitis (GPA/MPA) in 20 countries. This randomized, controlled trial assigned patients to either oral Tavneos® (30mg twice daily) or oral prednisolone on a tapering schedule. All patients received induction treatment with cyclophosphamide or rituximab. The study met its primary endpoints of disease remission at week 26, defined as Birmingham Vasculitis Activity Score (BVAS) of 0 at week 26 and not taking glucocorticoids for treatment of ANCA-associated vasculitis in the previous 4 weeks, and sustained remission at both weeks 26 and 52 defined as a BVAS of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to week 52. Compared to a prednisolone-based regimen, the Tavneos®-based regimen demonstrated non-inferiority in terms of remission at week 26, and superiority in terms of sustained remission at week 52. Serious adverse events (excluding worsening vasculitis) occurred in
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in
About GPA and MPA
GPA and MPA are the two main forms of ANCA-associated vasculitis which is a systemic disease in which inappropriate 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 and lung as major targets, and may be fatal if not treated.
Treatment of GPA/MPA consists of courses of potent immuno-suppressants, in combination with high-dose glucocorticoids (steroids) for prolonged periods of time. However, the unmet medical need remains high as these patients face significant risk of complications, both from their disease and adverse effects from medications, including from long-term use of glucocorticoids. Treatment goals are to achieve sustainable remission to reduce vascular damage and preserve organ function while minimizing the side effects of current treatments.
About Tavneos® (avacopan)
Tavneos® (avacopan) is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By blocking this receptor (C5aR1) for the pro-inflammatory complement system fragment, C5a on inflammatory cells such as neutrophils, Tavneos® reduces the ability of those cells to do damage in response to C5a activation. Moreover, Tavneos® selective inhibition of only the C5aR1 is expected to leave the formation of the beneficial C5b-9 complex intact.
Tavneos® was developed by ChemoCentryx, Inc., who is also developing Tavneos® for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS). The
VFMCRP has a licensing agreement with ChemoCentryx, Inc., to commercialize Tavneos® outside the US.
# # #
View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005538/en/
Media Contact
Mobile: +41 79 957 96 73
Email: media@viforpharma.com
Source: Vifor
FAQ
What does NICE's recommendation mean for patients with GPA/MPA?
When will Tavneos® be launched in the UK?
What were the results of the clinical trials for Tavneos®?
How does Tavneos® work for treating GPA and MPA?