Boehringer Ingelheim Release: Praxbind (idarucizumab) Reimbursed In England, Ireland And Wales
BRACKNELL, England--(BUSINESS WIRE)--Praxbind® (idarucizumab) is now available to be used commercially in England, Ireland and Wales after the Health Technology Appraisal bodies in these countries agreed that it is eligible for full reimbursment without the need for a full appraisal.
“I’m proud that Boehringer Ingelheim is again continuing to lead the way in anticoagulation care for patients in the United Kingdom and Ireland”
Idarucizumab rapidly and specifically reverses the anticoagulant effect of Pradaxa® (dabigatran etexilate)2 for patients needing emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding.1
Idarucizumab received its European Commission marketing authorisation in November 2015 and is the first and only specific reversal agent for a NOAC to be granted a licence in the European Union.1
Welcoming the news Professor Klaus Dugi, Medical Director and Managing Director Boehringer UK and Ireland said
“Anticoagulants offer important benefits to patients but there are going to be very rare circumstances when rapid reversal of the anticoagulation effect of dabigatran is beneficial. The decision by NICE, AWMSG and NCPE supports availability of, Idarucizumab, to doctors in England, Wales and Ireland is fantastic news.
“While we do not anticipate that it will be used regularly there can be no doubt that its availability will provide added confidence for prescribers when choosing dabigatran for their patients.
“I’m proud that Boehringer Ingelheim is again continuing to lead the way in anticoagulation care for patients in the United Kingdom and Ireland”.
NOTES TO THE EDITORS
About the idarucizumab Clinical Trial Programme
Praxbind (idarucizumab) was discovered and developed by Boehringer Ingelheim scientists. The research programme was initiated in 2009, before Pradaxa® (dabigatran etexilate) was launched in Europe in 2011.
The company completed three phase I trials of idarucizumab in human volunteers and is continuing to evaluate idarucizumab in RE-VERSE AD™ (NCT 02104947, EudraCT 2013-004813-41), a phase III global study that includes patients taking dabigatran etexilate who require emergency procedures or suffer a life threatening or uncontrolled bleeding.3-5,6,7 The study has been underway since May 2014, enrolling patients in more than 35 countries.3 The RE-VERSE AD™ global phase III patient study is ongoing to capture further data on the efficacy and safety profile of idarucizumab.
Idarucizumab is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran.7 Idarucizumab binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.7
Idarucizumab is approved for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery / urgent procedures or in life-threatening or uncontrolled bleeding.1
Regulatory reviews and submissions in other countries are ongoing. Boehringer Ingelheim plans to submit idarucizumab in all countries where dabigatran is licensed.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.co.uk
1. Praxbind® Summary of Product Characteristics, Boehringer Ingelheim, 2015.
2. Pradaxa® Summary of Product Characteristics, Boehringer Ingelheim,2015
3. Pollack C. V., et al. Idarucizumab for Dabigatran Reversal. NEJM. 2015;373:511-520.
4. Glund S, et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015;386:680–690.
5. Glund S. et al. Idarucizumab, a Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Elderly and Renally Impaired Subjects. Oral presentation on 8 December 2014 at The 56th American Society of Hematology Annual Meeting & Exposition, San Francisco, USA. Blood. 2014;124:Abstract 344.
6. Glund S, et al. A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran. Thromb Haemost. 2015;113:943–951.
7. Pollack C. V. et al. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015;114(1):198-20.
Boehringer Ingelheim Limited
Corporate Affairs Manager
Tel: +44 (0)1344 742534