Business Wire

Updated Phase III Results Reinforce Safety and Efficacy of Praxbind® (idarucizumab) in Urgent Situations

Del

Boehringer Ingelheim announced updated results from data for 494 patients participating in the ongoing phase III RE-VERSE AD study, which showed that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate).1 Idarucizumab, marketed as Praxbind®, is the first and only approved specific reversal agent for a non vitamin K antagonist oral anticoagulant (NOAC) and RE-VERSE AD is the largest patient study investigating a reversal agent for a NOAC.2-4 The updated results were presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, Louisiana.1

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161116005651/en/

RE-VERSE AD includes the types of patients healthcare professionals may treat in real-world emergency settings.2 The study enrolled patients treated with dabigatran who had uncontrolled or life-threatening bleeding (Group A, n=298, 60 percent) or required emergency surgery or an invasive procedure (Group B, n=196, 40 percent).1 This includes severely ill or injured patients (e.g. patients in an automobile accident with multiple injuries, patients with aortic aneurysm or patients receiving an organ transplant) who as such require urgent reversal of dabigatran.2

The primary endpoint of reversal of the anticoagulant effect of dabigatran within four hours was 100 percent1,2, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT) (95% CI, 100-100).1,2 Of note, reversal was evident immediately after administration of idarucizumab.1 For Group A patients with extracranial bleeding, median time to confirmation of haemostasis was 3.5 to 4.5 hours, depending on anatomical location.1 The source of bleeding was similar to the previous interim analysis (45 percent gastrointestinal, 33 percent intracranial haemorrhage).1,5 In Group B, 93 percent of patients experienced normal haemostasis during surgery, and the median time to the operating room was 1.6 hours after administration of idarucizumab.1

No safety signals attributed to idarucizumab were detected. All serious adverse events reported were considered to be related to the index event or comorbidities rather than to study treatment. Thrombotic events occurred in 6.3 percent (31/494) of patients within 90 days after idarucizumab administration. Approximately two-thirds of these patients received no anticoagulation prior to the event. Mortality rates were 12.3 percent (Group A) and 12.4 percent (Group B) at 30 days, and 18.7 percent (Group A) and 18.5 percent (Group B) at 90 days. 1

“The availability of idarucizumab as a reversal agent for dabigatran is an important development in anticoagulation care, and RE-VERSE AD is the most robust examination of its real-world use and impact,” said Dr. Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, US. “These results further support that, although idarucizumab is likely to be rarely used in light of the safety profile of dabigatran, a specific reversal agent provides an important therapeutic option for physicians and patients.”

“With these results, we have an unprecedented wealth of data on the use and effects of idarucizumab in urgent situations,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These insights, together with the confirmed safety profile of dabigatran, can truly give physicians confidence in choosing a NOAC that provides a new level of care for their patients.”

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. 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.

~ENDS~

Please click on the link below for ‘Notes to Editors and References’:

http://www.boehringer-ingelheim.com/press-release/updated-phase-iii-results-reinforce-safety-and-efficacy-of-praxbind

Contact information

Boehringer Ingelheim GmbH
Friederike Middeke
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
E-mail: press@boehringer-ingelheim.com
Twitterhttp://twitter.com/Boehringer
or
More information
www.boehringer-ingelheim.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

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

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

Capgemini Gives Technology a Human Touch, with a New Brand Identity Designed by BrandPie.18.10.2017 08:30Pressemelding

Capgemini, one of the world’s leading global technology and consulting firms, yesterday launched its new brand identity, designed by strategic brand consultancy BrandPie. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018005101/en/ Capgemini's new brand identity, designed by BrandPie BrandPie worked in close collaboration with Capgemini’s leadership team over 15 months to create a dynamic digital-first brand identity and wordmark, inspired by the handwriting of Serge Kampf, Capgemini’s founder. Meanwhile, its iconic spade emblem has been redrawn to reflect the world the business is now in. Coinciding with the Group’s 50th anniversary, this is the first overhaul of Capgemini’s brand identity since 2004, and has been crafted to ensure that it remains ahead of its peers in its

GSMA and AIC Encourage Greater Engagement among RCEP Countries to Enable a Truly Pan-Asian Digital Economy18.10.2017 07:00Pressemelding

The GSMA and the Asia Internet Coalition (AIC) today urged the participating countries of the Regional Comprehensive Economic Partnership (RCEP) for greater commitment and engagement. As representatives of leading companies that operate in the region and promote the digital economy, the GSMA and AIC believe that the RCEP can play a critical role in enabling positive policy development in the digital economy and reducing or removing barriers and restrictions that suppress digital trade and investments in the Asia Pacific region. “The RCEP will play an increasingly important role in the region’s digital future, as it involves all of the largest Asian economies, including both ASEAN and non-ASEAN nations,” said Alasdair Grant, head of Asia Pacific for the GSMA. “This is even more critical in light of the stalled talks on the Trans-Pacific Partnership, as well as the growing need for innov

Utimaco Launches PaymentServer 3.00.0 To Help Payment Industry Reach PCI Compliance18.10.2017 06:11Pressemelding

As the Payment Card Industry (PCI) continues to heat up, Utimaco is providing enterprises in the banking and financial services sector with the opportunity to achieve PCI compliance through its latest launch, PaymentServer 3.00.0. The new PaymentServer is a PCI Standards Security Council accredited PCI PIN Transaction Security Hardware Security Module Version 2 (PCI PTS HSM V2) solution that comes with a complete offering, including the HSM, a Software Development Kit, and additional services such as integration support, certification assistance and tiered maintenance. All of this allows Utimaco partners to focus on business innovation with the assurance that their work remains or regains PCI compliance. Using Utimaco’s flexible software development kit, companies can reach full PCI compliance for a solution or environment based on the standard product offering from PaymentServer or vi

Norsk Titanium Dedicates Plattsburgh Machines at Ceremony with New York Governor18.10.2017 06:00Pressemelding

Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, held a dedication ceremony yesterday of its Plattsburgh Development and Qualification Center (PDQC) in Plattsburgh, New York. This facility, which currently houses nine of Norsk’s proprietary Rapid Plasma DepositionTM (RPD) titanium printing machines, signifies the partnership between Norsk and the state of New York. The site will produce aerospace components for Boeing and other aerospace producers. State and local officials, including New York Governor Andrew Cuomo, Howard Zemsky of Empire State Development, Michael Cashman of the Town of Plattsburgh, the City of Plattsburgh Mayor Colin Reed and Garry Douglas of the North Country Chamber of Commerce participated in the ceremony. "Norsk could have chosen anywhere in the nation to set up their

The Body Shop Switzerland Transforms the Shopping Experience with Axway18.10.2017 06:00Pressemelding

The Body Shop, an international beauty business, is leveraging Axway (Paris:AXW) (Euronext: AXW.PA), a catalyst for digital transformation, to improve the customer experience at retail stores throughout Switzerland. With Axway Appcelerator, The Body Shop has been able to rethink its customer loyalty program, integrate massive amounts of data, and successfully implement an innovative new mobile application to increase in-store purchases. The new Axway-powered Love Your Body Club mobile app has enabled The Body Shop to deliver personalized and contextualized experience to more than 90,000 customers in Switzerland. Formed in 1976, The Body Shop is an international, ethical beauty business that sells more than 900 different beauty products in 2,600 stores worldwide and online. To build on its successful business in Switzerland and enhance the experience it offers to customers in the

SailPoint Propels the Identity-Aware Enterprise with New Version of IdentityIQTM18.10.2017 05:01Pressemelding

From Navigate ’17, SailPoint, the leader in enterprise identity management, today announced several enhancements to its open identity platform, designed to further enable identity to be woven throughout the IT operations and security fabric of global organizations. Now, critical identity governance processes, such as separation-of-duty policies and access request approvals, can be leveraged as a shared service within solutions that help support an identity-aware ecosystem. This accelerates the time it takes to get visibility into and control over crucial resources, while also enabling a unified approach to identity governance that shares identity context across all IT and security investments. With an identity-aware IT ecosystem, customers are better prepared to mitigate, identify and contain data breaches. The latest iteration of SailPoint’s IdentityIQ, which i

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom