Business Wire

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

Del

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.

About Otsuka

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.

OPEL/0718/COMS/1054

OPUK/0718/JIN/1416

July 2018

Contact information

Otsuka
(In Europe)
Alison Ross
Head of Communications – Europe
Otsuka Pharmaceutical Europe Ltd.
+44 (0)203 7475000
ARoss@Otsuka-Europe.com
or
(Outside Europe)
Jeffrey Gilbert
Leader, Pharmaceutical Public Relations
Otsuka Pharmaceutical Co., Ltd.
+81 3 6361 7379
Gilbert.jeffrey@otsuka.jp

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

In the Wake of the Ongoing Floods in Kerala; UAE Exchange and Unimoni Waive Service Fee on Remittances to Kerala Chief Minister's Distress Relief Fund16.8.2018 09:30Pressemelding

Leading money transfer, foreign exchange and payment solutions brands, UAE Exchange and Unimoni, have waived service fee on remittances to Kerala Chief Minister's Distress Relief Fund in the wake of the catastrophic floods that has ravaged the Indian state of Kerala. The initiative which enables the global Indian diaspora to contribute to the relief efforts, follows a personal contribution of two crore rupees made by the Group Chairman and noted UAE-based businessman and philanthropist, Dr. Bavaguthu Raghuram Shetty, to help those affected by the floods. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180816005229/en/ Promoth Manghat, Executive Director, Finablr and Group CEO (Photo: AETOSWire) Promoth Manghat, Executive Director, Finablr and Group CEO, said, “As a committed corporate citizen, who firmly believes in helping communities in times of need, it was our responsibility to do all that is in our power to aid the peopl

BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza16.8.2018 05:00Pressemelding

BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of influenza (flu). Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA-based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines, following BioNTech’s completion of a first in human clinical study. BioNTech will receive $120 million in upfront, equity and near-term research payments and up to an additional $305 million in potential development, regulatory and commercial milestone payments. In addition, BioNTech will receive up to double-digit tiered royalty payments associated with worldwide sales if the program reac

Maxion Wheels to Showcase Market-Leading Light Weight Commercial Vehicle Wheels at REIFEN 201816.8.2018 04:05Pressemelding

Maxion Wheels, the world’s largest producer of wheels, announced today its participation in REIFEN, the leading tire and wheel industry event in Europe, from Sept. 11 – 15, 2018 in Hall 12.1 / Stand D24. For the first time, REIFEN will be co-located with Automechanika Frankfurt at the Messe Frankfurt. “REIFEN is the premier event for European tire and wheel manufacturers and resellers, bringing us together to meet and collaborate on the important aftermarket themes of innovation, service and delivery,” stated Mark Gerardts, Vice President of Global Sales and Marketing, Maxion Wheels. “After a highly popular launch to truck and trailer OEMs in 2017, we’re excited to have the industry’s lightest mass production steel wheel now available to our aftermarket distributors. This wheel, along with several others, including our new 10.00W-20 wide base tubetype and tubeless heavy duty armored vehicles wheel are great examples of our continued efforts to bring our OE multi-application innovations

Lenovo Accelerates Turnaround with Back-to-Back, Double-Digit Quarterly Revenue Growth15.8.2018 23:40Pressemelding

Lenovo Group (HKSE: 0992) (PINK SHEETS: LNVGY) today announced results for its first fiscal quarter ended June 30, 2018. For the second straight quarter, Lenovo achieved strong double-digit growth in revenue year-on-year. Group revenue reached US$11.91 billion, up 19% year-on-year. The company also reported strong pre-tax income during the quarter of US$113 million, an improvement of US$182 million year-on-year, as profitability improved across all businesses. In the first fiscal quarter, Lenovo’s profit attributable to equity holders grew to US$77 million, up US$149 million year-over-year. Basic earnings per share in the first fiscal quarter was 0.65 US cents or 5.10 HK cents. “As we persistently execute our 3-wave strategy, all our businesses made solid improvements in both revenue and profitability. Lenovo has passed the turning point and entered a phase of ‘acceleration’ - accelerating the execution of our transformation strategy and accelerating the rising momentum in business per

CORRECTING and REPLACING Ebola Successfully Neutralized by Latest Generation Polyclonal Immunotherapy15.8.2018 22:37Pressemelding

Please replace the release with the following corrected version due to multiple revisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005602/en/ New Ebola immunotherapy developed by SAB Biotherapeutics uses natural human polyclonal antibodies to combat disease. (Photo: SAB Biotherapeutics) The corrected release reads: EBOLA SUCCESSFULLY NEUTRALIZED BY LATEST GENERATION POLYCLONAL IMMUNOTHERAPY Promising new platform can rapidly respond to emerging infectious diseases Sioux Falls, SD, August 15, 2018 – SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical company, today announced that its anti-Ebola immunotherapy (SAB-139) provided “100% protection against a lethal dose of the Ebola virus” in a recent animal study published in The Journal of Infectious Diseases . The study was conducted at the Integrated Research Facility, National Institute of Allergy and Infectious Diseases, National Institutes of He

Ebola Successfully Neutralized by Latest Generation Polyclonal Immunotherapy15.8.2018 17:43Pressemelding

SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical company, today announced that its anti-Ebola immunotherapy (SAB-139) provided “100% protection against a lethal dose of the Ebola virus” in a recent animal study published in The Journal of Infectious Diseases . The study was conducted by the National Interagency Confederation for Biological Research and other collaborators including United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Naval Medical Research Center (NMRC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005602/en/ New Ebola immunotherapy developed by SAB Biotherapeutics uses natural human polyclonal antibodies to combat disease. (Photo: SAB Biotherapeutics) According to the World Health Organization, Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans with an average fatality rate around 50%.