Boehringer Ingelheim receives positive CHMP opinion for use of Pradaxa ® (dabigatran etexilate) for the treatment and prevention of venous thromboembolic events in children from birth to less than 18 years of age
Boehringer Ingelheim today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the proposed indication for Pradaxa® (dabigatran etexilate) for the treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in pediatric patients from birth to less than 18 years of age.
If the proposed indication is approved by the European Commission (EC), pediatric patients and healthcare professionals will have access to an oral anticoagulant therapy for which the risk-benefit profile has been thoroughly assessed by a health authority. At present, there is no approved therapy for the treatment or prevention of blood clots in veins (VTE) for children, and current standard of care (SOC) is associated with a range of limitations – including the need for frequent monitoring of anticoagulation level or burden of daily injections.1
“It is important that healthcare professionals have access to an oral anticoagulant treatment that has gone through rigorous testing, and is as convenient as possible for children,” said Leonardo R. Brandão, Thrombosis Program Director, Associate Professor, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Canada. “If adopted by the EC, this positive opinion could potentially lead to the availability of a treatment option that can be administered orally, does not require routine laboratory monitoring or dose titration, and is available in formulations targeted to specific age groups, including younger patients.”
“Dabigatran has a proven positive safety profile in adults, demonstrated across clinical and real-world studies,3 and we are delighted that it has now been confirmed in pediatric patients too,” said Waheed Jamal, Corporate Vice President, Head of CardioMetabolism Respiratory Medicine, Boehringer Ingelheim. “This positive opinion provides further evidence that dabigatran is suitable for use across a wide range of patient populations, with clinical experience that equates to over 10 million patient-years across all licensed indications to date. If approved, it will bring a new therapy where there are currently no licensed treatment options available.”
The positive CHMP opinion is based on a dedicated pediatric clinical program. The DIVERSITY trial demonstrated that dabigatran was non-inferior to SOC for pediatric patients at high risk of VTE, with comparable bleeding rates,2 while the Brandão L et al. study showed favorable safety results with dabigatran in children with VTE and persistent thrombosis risk factors.1
The expected approval represents an important milestone for dabigatran, building on the outcomes of its associated trials and potentially widening its patient population.
About the DIVERSITY study, Ablisetti M et al.
This open-label, randomized (1:2), parallel-group, phase 2b/3 non-inferiority trial evaluated the efficacy and safety of SOC versus dabigatran using a pediatric dabigatran dosing algorithm (age- and weight-adjusted nomogram) in children with acute VTE aged 12 to <18, 2 to <12, and birth to <2 years requiring anticoagulation therapy for ≥3 months.2
The primary composite efficacy endpoint was the proportion of children with complete thrombus resolution, and freedom from recurrent VTE or VTE-related death. The secondary endpoints were safety and pharmacokinetic/pharmacodynamic relationships.2
The results from the DIVERSITY trial demonstrated that dabigatran was non-inferior to SOC in efficacy for acute VTE treatment, with similar pharmacokinetic/pharmacodynamic relationships to adults, and may be a suitable alternative to SOC.2
About the secondary VTE prevention study, Brandão L et al.
The open-label, single-arm, prospective cohort, Phase III trial is the first study of its kind to describe outcomes in children treated with a direct oral anticoagulant for secondary VTE prevention. In the study, approximately 200 children received dabigatran for up to 12 months. The primary endpoints for this study included VTE recurrence, bleeding events and mortality at 6 and 12 months.1
The study showed a low overall frequency of recurrent VTEs and any bleeding events.1 Based on these results, the authors concluded that this trial showed favorable safety results with dabigatran in children with VTE and persistent thrombosis risk factors.1
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/positive-chmp-opinion-dabigatran-children
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. It is directed to the international audience outside Germany. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Media + PR
Phone: +49 6132 77 144553
Mobile: +49 1516 89 47444
Fax: +49 6132 77 6601
About 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.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s23.7.2021 16:05:00 CEST | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination. “We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson
ForumPay Teams Up with Bambora to Conquer the Crypto-to-Fiat Payments Market23.7.2021 15:16:00 CEST | Press release
ForumPay, an international cryptocurrency-to-fiat payment service provider, has established a partnership with the global payments provider Bambora, a Worldline brand, to bring seamless crypto payment solutions to merchants and online shoppers. The partnership will cater to a large global audience and offer expanded payment options for both shoppers and merchants. ForumPay continues its march to dominate the growing crypto payments ecosystem for merchants around the world. “ForumPay provides merchants with a seamless, secure and instant processing solution to accept payments from the more than 54 million active crypto wallet users around the world. By providing a payments service for processing crypto into fiat that functions as naturally as card payments, ForumPay enables merchants with a familiar feeling payments alternative that also gives them a competitive advantage by tapping into the fastest growing consumer base on the planet.” says Joshua Tate, CEO of ForumPay. “We are very ex
Wipro Recognized as 2021 Microsoft Modernizing Applications Partner of the Year23.7.2021 14:54:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has won the 2021 Microsoft Partner of the Year Award in the Modernizing Applications category. In addition, Wipro was also named as a category finalist in the 2021 AI Partner of the Year category, solidifying its reputation as an innovator in multiple sectors. This recognition highlights Wipro’s deep expertise and ability to go above and beyond for its customers, powered by an established partnership with Microsoft. Even when working with complex customer environments, spanning across hundreds of servers with different applications of different versions, Wipro was able to help customers meet their business needs and leverage the power of public cloud in an efficient way. “Global enterprises have embraced modernization at an unprecedented scale and pace, and the demands of the past year show no sign of easing. We are honor
Merck Announces Appointment of Head of China & International for Healthcare23.7.2021 13:45:00 CEST | Press release
Merck, a leading science and technology company, today announced that Hong Chow will join its Healthcare business sector as Head of China & International on October 1. In this role at Merck, Chow will lead China, Japan as well the regions Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, the franchise of Cardiovascular Metabolism & Endocrinology (CM&E), and the Global Business Innovation team. Chow will report to Peter Guenter, Member of the Executive Board of Merck and CEO Healthcare. She will serve as a member of the Healthcare Executive Committee, and be based in Shanghai, China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005186/en/ Merck Announces Appointment of Head of China & International for Healthcare (Photo: Business Wire) “Hong’s international experience and strong track record of bringing innovative medicines to patients in need across both developed and emerging markets, most nota
H.I.G. WhiteHorse Refinances Grupo Recoletas23.7.2021 13:03:00 CEST | Press release
H.I.G. WhiteHorse, a credit affiliate of global investment firm H.I.G. Capital ("H.I.G.") is pleased to announce that it has arranged a refinancing package for Grupo Hospitalario Recoletas (“Recoletas”), which includes a significant growth capital component. Recoletas is a family-owned Spanish private hospital operator headquartered in Valladolid, Spain, with a leading position in the Castilla y Leon Spanish inland region. It operates 8 hospitals with c. 540 beds and 13 medical centres across 7 regions. H.I.G. WhiteHorse has committed €110 million in unitranche loans to refinance the borrower's existing indebtedness and provide additional capital to finance growth, supporting the Company’s expansion. Recoletas is currently developing ambitious projects to expand its healthcare services provided through hospitals and medical centers, as well as diagnostic imaging centers and radiotherapy units. Amando J. Rodríguez, President and CEO of Grupo Hospitalario Recoletas, said: “We are very ha
Schlumberger Announces Second-Quarter 2021 Results23.7.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second-quarter 2021. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2021Mar. 31, 2021Jun. 30, 2020SequentialYear-on-yearRevenue* $5,634 $5,223 $5,356 8% 5% Income (loss) before taxes - GAAP basis $542 $386 $(3,627) 40% n/m Net income (loss) - GAAP basis $431 $299 $(3,434) 44% n/m Diluted EPS (loss per share) - GAAP basis $0.30 $0.21 $(2.47) 43% n/m Adjusted EBITDA** $1,198 $1,049 $838 14% 43% Adjusted EBITDA margin** 21.3% 20.1% 15.6% 118 bps 561 bps Pretax segment operating income** $807 $664 $396 22% 104% Pretax segment operating margin** 14.3% 12.7% 7.4% 162 bps 694 bps Net income, excluding charges & credits** $431 $299 $69 44% 525% Diluted EPS, excluding charges & credits** $0.30 $0.21 $0.05 43% 500% Revenue by Geography International $4,511 $4,211 $4,224 7% 7% North America* 1,083 972 1,097 11% -1% Other 40 40 35 n/m n/m $5,634 $5,223 $5,356 8% 5% *Schlumberger di
Wyss Center Partners With Artiria Medical to Accelerate a Novel Therapy for Cerebral Vasospasm23.7.2021 11:59:00 CEST | Press release
The Wyss Center and Artiria Medical today announced a new partnership to accelerate the translation of a novel technology that has the potential to reduce deaths and improve quality of life for stroke patients. Artiria Medical, an early-stage medical device company focused on disruptive neurovascular products, has been developing the technology and is now joining forces with the Wyss Center, a non-profit organization dedicated to bringing state-of-the-art therapies to the patient. The team has received support from the Swiss Innovation Agency, Innosuisse, to test and validate the efficacy of the therapy preclinically, in preparation for human clinical studies. Stroke is the third leading cause of disability worldwide with more than 80 million people living with long-term impairments as a result. Some strokes result in bleeding in the brain. Such hemorrhagic strokes can lead to severe cerebral vasospasm - an uncontrolled contraction of brain arteries - in the days that follow, depriving