European Commission approves extension of indication for Otsuka’s JINARC® ▼ (tolvaptan) to include treatment of ADPKD patients with advanced chronic kidney disease (CKD stage 4)1
Otsuka Pharmaceutical Europe Ltd. (OPEL) today announced that the European Commission has approved an extension of indication for JINARC ® (tolvaptan) to include adult patients with CKD stage 4 Autosomal Dominant Polycystic Kidney Disease (ADPKD).1 JINARC® was approved in 2015 for the treatment of ADPKD in adults with CKD stage 1-3 at initiation of treatment and evidence of rapidly progressing disease.1 The decision to include stage 4 within the JINARC ® licence comes following the submission of additional data from the REPRISE study that supported the safety and efficacy of this treatment in patients with more advanced renal disease.
Data from the tolvaptan clinical trial programme were submitted to the European Commission, including the REPRISE2 study, which supported the efficacy and tolerability of JINARC ® observed in the previous TEMPO 3:43 and TEMPO 4:44 studies. These studies confirmed that tolvaptan slows the progression of ADPKD in patients with earlier (CKD stage 1-3) as well as those with advanced (CKD stage 4) stages of disease.2,3,4
JINARC ® is a selective vasopressin-2-receptor antagonist containing the active substance tolvaptan. It blocks receptors in the kidneys that are responsible for the action of vasopressin. Suppression of vasopressin activity reduces the formation and enlargement of cysts and protects kidney function in patients with polycystic kidney disease (PKD). ADPKD is a progressive genetic disorder affecting the kidneys, in which fluid-filled cysts develop in the kidneys over time, enlarging these organs and reducing their ability to function normally, leading to kidney failure in most patients.5 ADPKD is the most common type of PKD, and is the fourth leading cause of kidney failure.5,6 Approximately 70% of European patients with ADPKD progress to end-stage renal disease (ESRD) at a median age of 58 years.7
JINARC® is the only pharmacological treatment indicated to slow the progression of cyst development and renal insufficiency in ADPKD patients with evidence of rapidly progressing disease.
▼ This medicinal product is subject to additional patient monitoring. This will allow quick identification of new safety information. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to their relevant local bodies.
Notes to Editors
About the JINARC ® studies
The REPRISE study was a phase 3b, multi-centre, randomised-withdrawal, placebo-controlled, double blind trial involving 1,370 subjects, comparing the efficacy and safety of tolvaptan (45 to 120 mg/day, split-dose) in ADPKD patients with CKD between late stage 2 to early stage 4 (eGFR between 25 and 65 mL/min/1.73 m2). Results showed that tolvaptan significantly reduced the rate of estimated Glomerular Filtration Rate (eGFR) decline by 35% compared to placebo over 1 year (N=1,370; difference in eGFR change: is 1.27 mL/min/1.73 m2, 95% CI 0.86-1.68, P<0.001).2,8
TEMPO 3:4 was a phase 3, multi-centre, double-blind, randomised, placebo-controlled, parallel-arm 36-month trial involving 1,445 patients to determine long-term safety and efficacy of oral tolvaptan tablet regimens in adults with ADPKD. Results showed that tolvaptan slowed Total Kidney Volume (TKV) growth and eGFR decline, relative to placebo.3
TEMPO 4:4 was a two-year multi-centre, open-label extension study of TEMPO 3:4, including 871 subjects, designed to provide an additional 2 years data on the long-term efficacy and safety of tolvaptan in ADPKD. Although TEMPO 4:4 did not meet its primary TKV endpoint, results were suggestive of a disease-modifying effect on the secondary endpoint of renal function (eGFR).4
The results of the REPRISE study suggest that although the overall risks versus benefits will need to be carefully considered before initiating treatments in patients with late-stage ADPKD, in selected patients with CKD stage 4, JINARC ® has a positive benefit/risk balance.9,10
Treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has R&D programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka established a presence in Europe in 1974 and today Otsuka Pharmaceutical Europe Ltd. employs approximately 600 people who channel their passion and energy into converting the latest science into much-needed medicines.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 46,000 people worldwide and had consolidated sales of approximately EUR 9.8 billion in 2017.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Europe at www.otsuka-europe.com or visit our Twitter page www.twitter.com/otsukaeurope.
1 European Commission. Commission implementing decision of 26.7.2018 amending the marketing authorization granted by Decision C(2015)3676(final) for “Jinarc – tolvaptan”, a medicinal product for human use. 2018.
2 Torres V et al. Tolvaptan in later-stage autosomal dominant polycystic kidney disease. N Engl J Med 2017; 377(20): 1930-42.
3 Torres V et al. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012; 367(25): 2407-18.
4 Torres V et al. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrol Dial Transplant. 2017; 32(7): 1262.
5 National Kidney Foundation (2017) Polycystic Kidney Disease. Available at: https://www.kidney.org/atoz/content/polycystic [Last accessed: July 2018]
6 Chebib F et al. Autosomal Dominant Polycystic Kidney Disease: Core Curriculum 2016. Am J Kidney Dis. May 2016; 67(5): 792-810.
7 Spithoven EM et al. Analysis of data from the ERA-EDTA Registry indicates that conventional treatments for chronic kidney disease do not reduce the need for renal replacement therapy in autosomal dominant polycystic kidney disease. Kidney Int 2014; 86: 1244-52.
8 OPDC Data on file 2017
9 European Medicines Agency. CHMP extension of indication variation assessment report. 2018.
10 European Medicines Agency. Extension of indication variation. Final clinical assessment report. 2018.
Head of Communications – Europe
Otsuka Pharmaceutical Europe Ltd.
+44 (0)203 7475000
Leader, Pharmaceutical Public Relations
Otsuka Pharmaceutical Co., Ltd.
+81 3 6361 7379
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
SCG Chemicals Company chooses gPROMS modelling for digital design and operations22.3.2019 18:55:00 EET | Tiedote
Process Systems Enterprise (PSE), the Advanced Process Modelling company, today announced that it has signed a long-term agreement with SCG, one of the largest integrated petrochemical companies in South East Asia, to standardise on PSE’s gPROMS® modelling technology for digital design and operations. SCG applies advanced process models within digital design initiatives to explore the process decision space rapidly and effectively, in order to reduce uncertainty and make better, faster and safer design and operating decisions. This help them to accelerate innovation and optimise the design and operation of their process plants. Dr Suracha Udomsak, SCG’s Emerging Business Director and R&D Director, says, “at SCG Chemicals, advanced process modelling (APM) is a key element in our Digital Manufacturing platform. APM accelerates innovation by making the development workflow ‘faster, cheaper & safer’, which are key considerations for us. It is a core technology building block that enables u
Logicor Announces Results for Year Ended 31 December 201822.3.2019 17:29:00 EET | Tiedote
Logicor announces strong financial performance for the year ended 31 December Net Operating Income (NOI): €639 million, which represents year on year growth of 2.5%, reflecting our strategic focus on increasing occupancy and capturing market rental growth. Over 60% of NOI is generated in the key markets of the UK (26%), Northern Europe1 (21%) and France (15%). Gross Asset Value: €12.5 billion, a 3.3% increase in valuation, which reflects the strong performance of our portfolio, in particular in Northern Europe. EPRA Occupancy: 94.4%, with physical occupancy up 70 bps over the year, underpinned by strong growth in each of our three largest regions of the UK (+120 bps), Northern Europe (+110 bps) and France (+220 bps). LTV: 51%, down from 52% at year end 2017 following increases in property values. At year end, our debt to EBITDA ratio was 11.3x. Capital Structure In 2018 Logicor (rated BBB (Stable) by S&P) established a Euro Medium Term Note (‘EMTN’) programme and raised €1.8 billion of
Delticom AG/Mytyres.co.uk: Buying Great Value Tyres Online Doesn’t Mean Missing out on Professional Fitting22.3.2019 17:15:00 EET | Tiedote
Spring is just around the corner, and it’s time for drivers to start thinking about changing to summer tyres. However, a tyre check may show that your current summer tyres are getting old, worn out, or have visible damage, such as cracks or bumps. If this is the case, then it's time for a new set of tyres. The legal minimum tread depth is 1.6 mm, however experts recommend significantly more – summer tyres should be replaced even if the tread depth is 3 mm. Regardless of mileage, you should change your tyres at least every eight to ten years. This is because the rubber starts to harden, the tyres lose grip on the road, and driving performance is affected. Of course, a set of four new tyres is a significant investment – authorised workshops can often charge between 250 and 350 pounds. If you want to save money, consider the alternatives: the result is an increasing number of customers turning to online shops such as Mytyres.co.uk to buy new tyres. The market share of tyres sold online ha
Trueman Man Clinic Achieves 10000 Surgery Milestone with Its SWITCH Operation22.3.2019 16:00:00 EET | Tiedote
Trueman Man Clinic Network announced that the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation), has been successfully completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190322005013/en/ Trueman Man Clinic Network has been successfully completed the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation). The SWITCH Premature Ejaculation Surgery (SWITCH operation) developed in 2010 by Dr. Yang, the chief director of the Trueman Man Clinic Network, can reduce the side effects of penile neurectomy and maintain the stable reduction of the glans sensation. The Trueman Man Clinic Network is the leading hospitals for male enhancement surgeries in Korea consists of 11 clinics, with 16 doctors working. As of 2019, more than 43,000 man clinic surgeries have been performed. (Photo: Business Wire) The Trueman Man Clinic Network is the leading hospitals for m
Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible22.3.2019 14:22:00 EET | Tiedote
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). “Today’s submission brings us one step closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “We are incredibly grateful to the patients and investigators who participated in the MAIA clinical trial programme and look forward to working closely with the regulatory authorities to secure approval of this new combination.” The submission is supported by data from the Phase 3 MAIA (MMY3008) study, which were presented at the 60th Annual Meeting of the American
Bartek Ingredients Expands Leadership Team22.3.2019 01:35:00 EET | Tiedote
Bartek Ingredients Inc. recently completed a 4,000 ton/year capacity expansion for its malic and food-grade fumaric acid production facility, and today it announces the expansion of its leadership team, with the hiring of Jeff Billig as Vice President of Marketing & Business Development and Heinrich G. Schaefer as International Sales Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190321005785/en/ The global leader in malic and fumaric acid ingredients expands its leadership team. (Photo: Business Wire) Bartek’s investment in both its team and facilities reinforces its position as the leader in malic and fumaric acid globally and aligns with its mission to facilitate growth and increase global reach to better serve existing customers and markets while opening up new ones. Bartek’s addition of Billig and Schaefer lays the foundation for additional resource investment in the near future while rapidly increasing its sa
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme