Chugai's HEMLIBRA® Receives the World's First Regulatory Approval from FDA for Hemophilia A with Inhibitors
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the U.S. Food and Drug Administration (FDA) has approved the bispecific antibody emicizumab (US product name: HEMLIBRA® ) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. This represents the first regulatory approval for HEMLIBRA® around the world. The US Biologics License Application (BLA) was submitted by Genentech , a member of Roche Group.
“We are pleased that HEMLIBRA, a biopharmaceutical created by Chugai scientists based on their exceptional idea, has received its first regulatory approval,” said Chugai’s President & COO, Tatsuro Kosaka. “HEMLIBRA is a first in class biopharmaceutical which is an advancement on the current limited treatment options available for patients with hemophilia A with inhibitors. We anticipate that patients will receive significant potential benefits from HEMLIBRA, which enables once-weekly subcutaneous injection as well as reduction of the bleeding risk.”
This regulatory approval is based on the data from two clinical studies, the results of HAVEN 1 study (NCT02622321) and the interim analysis of HAVEN 2 study (NCT02795767) in patients with hemophilia A with factor VIII inhibitors. HAVEN 1 included adult and adolescent patients and HAVEN 2 included pediatric patients, and were both conducted under a collaboration between Chugai, Roche and Genentech. In the HAVEN 1 study, adults and adolescents with hemophilia A with inhibitors who received HEMLIBRA prophylaxis (n=35) had a statistically significant and clinically meaningful 87% (95% CI: 72.3-94.3, p<0.0001) 2 reduction in treated bleeds compared with those who received no prophylaxis (n="18)." interim results from the haven study, pediatric patients hemophilia a inhibitors showed that 87% of (95% ci: 66.4-97.2) hemlibra experienced zero bleeds. most common adverse events (aes) occurring 10% or more people pooled studies were injection site reactions, headache and joint pain (arthralgia). < p>
HEMLIBRA was reviewed by the FDA under Priority Review. It was granted Breakthrough Therapy Designation by the FDA in adults and adolescents with hemophilia A with inhibitors in September 2015. Outside the US, emicizumab has been filed in the EU in June 2017 and data from HAVEN 1 and HAVEN 2 are being reviewed under Accelerated Assessment by the European Medicines Agency. In Japan, the drug received orphan drug designation by the Ministry of Health, Labour and Welfare for the prevention and reduction of bleeding episodes in patients with congenital FVIIl deficiency (hemophilia A) who developed inhibitors to FVIII in August 2016, and a new drug application was filed in July 2017.
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.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals, and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2016 of Chugai totaled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english .
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.
Susan Chou, Osamu Kagawa
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skrive dig op her og du vil løbende modtage pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
CELLTRION15.12.2017 23:15 | pressemeddelelse
Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar
TAKEDA15.12.2017 13:36 | pressemeddelelse
Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease
TWISPAY15.12.2017 13:23 | pressemeddelelse
Bitcoin Romania and Twispay Announce Integration Partnership Providing Users with the Ability to Purchase Bitcoin with Bank Cards
PEACE-FORUM15.12.2017 12:40 | pressemeddelelse
Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum
CA-KENNEDY-WILSON15.12.2017 12:02 | pressemeddelelse
Kennedy Wilson Acquires 124-Unit Northbank Apartments in Dublin, Ireland for €45 Million
NV-NAC-FOUNDATION15.12.2017 10:02 | pressemeddelelse
AML BitCoin Enters Phase II of ICO
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum