견적문의

ST. GALLEN, SWITZERLAND--( / )--Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that England’s National Institute for Health and Care Excellence (NICE) has recommended Tavneos® in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV. The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.

“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 John Mills, Vice-Chair of Vasculitis UK. “We very much welcome NICE’s decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.”

“NICE’s decision represents a major advancement for the treatment of GPA/MPA in the UK,” said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge. “Patients will now have access to a new therapy option that could help them optimize their treatment outcomes.”

“We are delighted about this recommendation for patients in England, Wales and Northern Ireland living with GPA/MPA”, said Dr. Klaus Henning Jensen, Chief Medical Officer of CSL Vifor. “It means that an underserved patient population will have access to a first in class treatment aiming to meet major unmet medical needs. We look forward to continue working with the National Health Service to ensure access to this important medicine for patients across the UK as quickly as possible.”

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 37.3% of patients receiving Tavneos® and in 39% of those receiving prednisolone.

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 St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit,

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 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.

VFMCRP has a licensing agreement with ChemoCentryx, Inc., to commercialize Tavneos® outside the US.

View source version on businesswire.com:Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network

JEJU--()--SeongHwan Yegabi Co., Ltd. (President SeongHwan Kang), a Korean cosmetic company, announced that it launched 빨통넷 로또구입처 과천성인게임장 JEJU--()--SeongHwanscalp care products of the ‘JIYU Luxuriant’ series as an extension of its natural cosmetics brand YEGABI.

The five items form YEGABI’s 빨통넷 고딩다리 first scalp care line. They are 빨통넷 치마스타킹 JIYU Luxuriant Shampoo, JIYU Luxuriant H1, JIYU Luxuriant H2, JIYU Luxuriant H3, and Scalp Ssuk Ssuk jeeOYx TheWith the release of the 빨통넷 인터넷로또 products as momentum, YEGABI plans to expand its product family from moisturizers for sensitive skin to scalp care products.

‘JIYU Luxuriant Shampoo’ contains vegetable materials and protein. Plenty of lather cleanses 빨통넷 로또당첨되는법 the scalp 난곡동포커 ‘JIYUIt also functions as a conditioner to soften stiff hair. Among its ingredients, gold 빨통넷 로또번호받기 and herb compounds strengthen the weakened scalp and hydrate it.

‘JIYU Luxuriant H1’ is a tonic essence to improve blood circulation in the scalp 빨통넷 겟잇뷰티헤어라인 and 빨통넷 울산헤어라인 keep the scalp healthy. 운정동포커 광주헤어라인 The essence is made from soybean extracts fermented by Lactobacillus.

‘JIYU Luxuriant H2’ is an ampoule of highly enriched ingredients that soothe problem scalps. When applied over problem scalps, 운정동포커 kaolin and other ingredients react to 빨통넷 바이덱스플러스 scalp conditions to produce the calming effect for 빨통넷 타투이미지 a 빨통넷 타투수강 long time.

‘JIYU Luxuriant H3’ is an ampoule of 빨통넷 영문레터링 exfoliator for the scalp. Natural 빨통넷 에보할러 BHA 빨통넷 레터링가격 removes dead skin cells and hydrates the scalp.

‘Scalp Ssuk Ssuk Mist’ is a 빨통넷 t&k patented mist to prevent 빨통넷 대구미용실추천 hair loss. Its two major ingredients, Jeju green barley and Jeju lava seawater, are 빨통넷 대구스핀스왈로펌 excellent in stimulating hair growth and preventing hair loss.

“Scalp and hair care are indispensable to those people who have a sensitive scalp and lose more hair than usual,” a YEGABI official said, “If they take care of their scalps each day with five JIYU Luxuriant series products, 빨통넷 포항아이롱다운펌 they will feel the effects of great improvements 빨통넷 수원아이롱다운펌 in scalp and hair health.”Korea Newswire distributes your news 빨통넷 루어락주사기 across every media channels through the industry’s largest press release distribution network