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.
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
Global Electronic Toll Collection and Road Usage Charging market to reach €490 billion in 20302.12.2020 17:06:00 CET | Press release
As the UK government just announced it is considering Road Usage Charging (RUC) as a funding solution for its road network, RUC schemes are being pushed ahead around the world. In the US, Asia, Africa and Oceania, electronic tolling is becoming crucial to bridge financing gaps and substitute declining gas tax receipts. PTOLEMUS Consulting Group forecasts that 874 million global subscriptions in ETC/RUC schemes will be active by 2030, collecting over €490 billion every year by 2030. PTOLEMUS’ Electronic Tolling Global Study is the 3rd edition of its highly popular Electronic Tolling series of reports, and represents the most comprehensive review of the global ETC/RUC market to-date, including 950 pages of insights, data, analyses and forecasts. PTOLEMUS expects the global ETC/RUC market to grow at 13% CAGR to 2030, driven by multiple factors including: environmental policy, economic development, interoperability schemes and growth of cashless payments, propelled by COVID-19. Dr Andrew J
Continental Structural Plastics Perfects Carbon Fiber RTM Process, Launches Production Programs2.12.2020 16:27:00 CET | Press release
After winning a JEC Innovation Award in 2016 for its Lincoln MKS Decklid Concept – a TCA Ultra Lite® outer panel and a carbon fiber RTM prototype inner – Continental Structural Plastics (CSP) has fine-tuned its carbon fiber RTM (CF-RTM) process to the point that a premium automaker will be using the technology for closures on future vehicle platforms. These doors will feature both inner and outer panels as well as structural reinforcements molded using CSP’s advanced CF-RTM process. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201202005708/en/ The new carbon fiber RTM press installed at the CSP facility in Palmela, Portugal, will soon be running the company's first commercial applications of this technology. (Photo: Business Wire) When CSP set up its Center of Excellence for Lightweight Technologies and Carbon Fiber Processes in Pouancé, France, in 2013, the goal was to develop processes to make the use of carbon fiber in
Pricefx Reimagines Pricing Software with Groundbreaking Product Enhancements2.12.2020 15:30:00 CET | Press release
Pricefx, the global leader in cloud-native pricing software, today announced the new face of its pricing platform. Unity UI is a sleek, dynamic new look for all of Pricefx’s industry-leading pricing modules. The company has also launched PriceOptimizer AI, a next-generation price optimization solution powered by transparent and predictive machine learning and multi-agent AI. Finally, Pricefx introduced new Accelerators, pre-defined solution building blocks that quickly and easily incorporate best practice functionality. With these new enhancements, Pricefx is now more streamlined, powerful and agile than ever before. Now, businesses using Pricefx can get more done and price more effectively with fewer clicks. “2020 revealed the critical importance of pricing in a digital-first world and Pricefx invested heavily in developing and refining our pricing platform to ensure that businesses around the world can successfully use our software to build a path to growth,” said Marcin Cichon, CEO
Soar the Skies with Demon Avenger in New MapleStory M Update2.12.2020 15:00:00 CET | Press release
Starting today, Maplers can take to the sky with the new warrior class, Demon Avenger, in Nexon’s free-to-play mobile MMORPG, MapleStory M! This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201202005043/en/ MapleStory M (Graphic: Business Wire) Soaring through the battlefield with Demon Wings, the Demon Avenger joins the fray with an Exceed System that deals excessive damage. Using HP to cast skills, the Demon Avenger can easily recover using various healing abilities, including Blood Pact, in the midst of battle. A selection of limited-time events are also available, including: Demon Avenger Celebratory Log-in Reward Event: Players logging in from today through December 7, 2020 will receive a special gift to help their character level up once per account. Demon Avenger Growth Support Event: Until January 11, 2021, players who reach a certain level will receive additional in-game items useful for a specific character’s level-up
Uber, Rivian, JetBlue, Cabify, and Boom Supersonic Sign The Climate Pledge2.12.2020 15:00:00 CET | Press release
Today, during Web Summit 2020, Amazon (NASDAQ: AMZN) and Global Optimism announced that Boom Supersonic, Cabify, JetBlue, Rivian, and Uberhave joined The Climate Pledge, a commitment to be net-zero carbon by 2040—a decade ahead of the Paris Agreement’s goal of 2050. Signatories to The Climate Pledge agree to: Measure and report greenhouse gas emissions on a regular basis; Implement decarbonization strategies in line with the Paris Agreement through real business changes and innovations, including efficiency improvements, renewable energy, materials reductions, and other carbon-emission elimination strategies; Neutralize any remaining emissions with additional, quantifiable, real, permanent, and socially beneficial offsets to achieve net-zero annual carbon emissions by 2040. “By signing The Climate Pledge, companies around the world are making a bold commitment to help protect our planet from the devastating impacts of climate change,” said Jeff Bezos, Amazon founder and CEO. “The trans
DXC Technology and Microsoft Collaborate to Power a More Personalized, Intelligent, Secure and Modern Workplace Experience for Global Enterprises2.12.2020 14:30:00 CET | Press release
DXC Technology (NYSE: DXC) today announced an expanded strategic collaboration with Microsoft to deliver a more personalized, intelligent, secure and modern workplace experience to help companies to address rapidly evolving business challenges and customer and employee needs. DXC and Microsoft are joining forces to deliver a solution and suite of services that will help companies to empower their employees with a modern workplace experience and to ensure customers’ employees can seamlessly and securely work anytime, anywhere and on any device. Called DXC MyWorkStyle™, DXC brings the largest install base of workplace customers and the blueprint for the modern workplace experience. As part of the collaboration, Microsoft and DXC will work together to co-develop and deliver the solution, leveraging artificial intelligence and machine learning from millions of data points to create a modern workplace experience. DXC and Microsoft will bring together leading technology, engineering talent a