Chugai’s Hemlibra® Gains Positive CHMP Opinion in Severe Hemophilia A Without Inhibitors
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that Roche has received notification that the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Hemlibra®, a treatment for hemophilia A created by Chugai, for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A without factor VIII inhibitors, administered once weekly, every two weeks, or every four weeks. The CHMP has also adopted a positive opinion for additional dosing options of every two weeks or every four weeks in adults and children with hemophilia A with factor VIII inhibitors.
“We are thrilled that Hemlibra is expected to be approved shortly for people with severe hemophilia A without inhibitors in the Europe Union (EU). Also, I’m very pleased that people in the EU with hemophilia A will soon be offered multiple options of Hemlibra’s dosing interval regardless of their inhibitor expression,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Osamu Okuda. “Hemlibra is co-promoted by Chugai and Roche in Germany, France, and the United Kingdom, as is the case with the anti-rheumatic agent RoActemra®. We are committed to pursue our efforts in collaboration with Roche so that Hemlibra may further contribute to the treatment of hemophilia A.”
This positive opinion is based on results from two Phase III studies HAVEN 3 (NCT02847637) and HAVEN 4 (NCT03020160), conducted jointly with Roche and Genentech. HAVEN 3 study was conducted to evaluate the reduction of bleed rate of Hemlibra subcutaneous injection once a week and once every two weeks in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII. HAVEN 4 study was conducted to evaluate efficacy, safety, and pharmacokinetics of Hemlibra subcutaneous injection every four weeks in people with hemophilia A (12 years of age or older), with and without inhibitors to factor VIII.
In Japan, Chugai obtained regulatory approval for Hemlibra from the Ministry of Health, Labour and Welfare in December 2018 for an additional indication of prophylactic treatment for people with hemophilia A without inhibitors to factor VIII, as well as for additional dosage and administration as a biweekly or every four-week treatment for people with hemophilia A with inhibitors to factor VIII.
Chugai’s HEMLIBRA® Receives Regulatory Approval from U.S. FDA
for Hemophilia A without Inhibitors
Press release issued on October 5, 2018
Chugai’s HEMLIBRA® Subcutaneous Injection Receives Approval
for Hemophilia A without Inhibitors and Extension of Dosing Interval --
HEMLIBRA is now available for Hemophilia A, regardless of inhibitor
Press release issued on December 21, 2018
About Severe Hemophilia A
People with severe hemophilia A is defined as the condition with less than 1 % of factor VIII levels. Hemophilia A affects around 320,000 people worldwide, 1,2 approximately 50-60% of whom are expected to have a severe form of the disorder3.
1) WFH. Guidelines for the management of haemophilia. 2012 [Internet;
cited 2018 July]. Available from:
http://www1.wfh.org/publications/files/pdf-1472.pdf. (as of February 1, 2019)
2) Berntorp E, Shapiro AD. Modern haemophilia care. The Lancet 2012; 370:1447-1456.
3) Marder VJ, et al. Hemostasis and Thrombosis. Basic Principles and Clinical Practice. 6th Edition, 2013. Milwakee, Wisconsin. Lippincott Williams and Wilkin.
Chugai Pharmaceutical is one of Japan’s leading research-based
pharmaceutical companies with strengths in biotechnology products.
Chugai, based in Tokyo, specializes in prescription pharmaceuticals and
is listed on the 1st section of the Tokyo Stock Exchange. As an
important member of the Roche Group, Chugai is actively involved in R&D
activities in Japan and abroad. Specifically, Chugai is working to
develop innovative products which may satisfy the unmet medical needs,
mainly focusing on the oncology area.
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.
Trademarks used or mentioned in this release are protected by law.
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
For US media
Chugai Pharma USA Inc.
For European media
Chugai Pharma France SAS
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Om Business Wire
(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
Telna Launches New eSIM Solution at MWC Barcelona 201924.2.2019 00:00:00 | Pressemelding
Telna, a vertically integrated Network-as-a-Service (NaaS) provider of global end-to-end connectivity solutions, today is adding eSIM technology to its platform. The new resilient and efficient eSIM architecture will be showcased at Mobile World Congress Barcelona 2019, from February 25th - February 28th at Telna’s booth in Hall 1, Stand 1B80. “eSIM technology is another example of a global trend in digital transformation set to disrupt cellular connectivity,” says Gregory Gundelfinger, CEO of Telna. “Our customers now have access to both Consumer and IoT/M2M eSIM that is bundled with the rest of our software-defined network services.” eSIM is an embedded SIM card, meaning there is no physical SIM card and no physical swapping of SIM cards. It's easy to add data plans and is endorsed by the GSMA. “The virtualization of the SIM card removes one of the largest barriers when switching between networks, the physical SIM card,” says Gundelfinger. The Telna eSIM allows users to access their
Hilton Launches New Brand, Signia Hilton, Delivering Sophisticated Travel While Reimagining Meetings and Events22.2.2019 17:00:00 | Pressemelding
Hilton (NYSE: HLT) today announced the launch of Signia Hilton, its dynamic, new meetings-and-events-focused brand. The portfolio of hotels is setting out to transform the industry for meeting professionals and sophisticated business travelers by infusing state-of-the-art technology and design into every aspect of the guest experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005071/en/ The brand further reinforces Hilton’s commitment to innovation that meets the evolving needs of today’s travelers and will bring premium experiences to top urban and resort destinations around the world. “In our 100th year of hospitality, we are more focused than ever on providing exceptional experiences to all of our guests – and that includes evolving those experiences to meet their changing needs,” said Christopher J. Nassetta, president and CEO, Hilton. “We are proud to launch Signia Hilton, which exemplifies our innovative sp
Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans22.2.2019 16:30:00 | Pressemelding
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System. The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1. Raymond W. Cohen, Chief Executive Officer of Axonics, said, “Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our te
Fantastec Joins Forces with Arsenal FC Launching Official Blockchain Collectibles App22.2.2019 14:30:00 | Pressemelding
Fantastec announced today its first football licensing agreement with Premier League club Arsenal FC for a new blockchain authenticated collectibles app called Fantastec SWAP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005277/en/ Arsenal players appear on Fantastec SWAP in official licensing deal (Graphic: Business Wire) London-based Fantastec is a leading sports fan technology innovator, and its blockchain based ‘SWAP’ app will have broad appeal to global sports fans, gamers and sports card collectors alike. Fantastec SWAP unlocks unique and authentic club content through the app, like player autographs and exclusive footage. With its innovative blockchain technology, fans around the world can now discover, collect and swap officially licensed club collectibles with other fans with complete trust. “Fantastec SWAP is a game-changer for international football fans as well the sports collectibles industry,” commented
Volkswagen Protects Virtual Key Sharing App with Trustonic Application Protection22.2.2019 13:42:00 | Pressemelding
Volkswagen is working with mobile cyber security leader Trustonic to enable customers to use smartphones to access their vehicles, and to securely share their digital car keys to grant access to others via a smartphone app. Volkswagen is using the Trustonic Application Protection (TAP) platform to secure the mobile app and ensure that sensitive information and key transfer requests are securely displayed to, and approved by, a real authenticated user on a trusted device and not by hackers or malware simulating a user or device. “The smartphone is becoming the vehicle key of the future and our We Connect service is the interface for this today in the new Volkswagen Passat,” comments Alf Pollex, Head of Infotainment and Connected Car at Volkswagen AG. “The user installs the We Connect app on their smartphone which is then authorized via the infotainment system with a Transaction Number. The Mobile Key will be compatible with Android-based Samsung devices. No mobile network connection is
Mundipharma EDO GmbH: US FDA grants Orphan Drug Designation for etoposide toniribate in relapsed/refractory biliary tract cancer22.2.2019 13:30:00 | Pressemelding
Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted Orphan Drug Designation (ODD) to etoposide toniribate for the treatment of relapsed/refractory biliary tract cancer, also known as cholangiocarcinoma.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005126/en/ Biliary tract cancer is a rare tumour with approximately 8,000 patients diagnosed in the US every year and 10,571 in Europe.4,5 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Radical surgery is the only curative treatment for biliary tract cancer but, in most cases, the cancer is inoperable. Patients who fail first-line chemotherapy have limited treatment options and the standard of