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» FDA and EMA Reaffirm Important Health Benefits and Safety of Pradaxa® (dabigatran etexilate) for Patients with Atrial Fibrillation
FDA and EMA Reaffirm Important Health Benefits and Safety of Pradaxa® (dabigatran etexilate) for Patients with Atrial Fibrillation
BUSINESS WIRE / ME NewsWire - INGELHEIM, Germany - Tuesday, November 6th 2012
New FDA data safety assessment supports previous clinical evidence on the safety of the anticoagulation therapy and reports new Pradaxa® and warfarin patients to have similar bleeding rates
Comprehensive efficacy and safety evaluation by the EMA leads to recommendation for renewal of the marketing authorisation for Pradaxa® to ensure ongoing patient benefit
For Non-US, Non-UK & Non-Canadian Media Only
Following independent regulatory appraisals of the safety and efficacy of the anticoagulation therapy Pradaxa®, both the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) have reconfirmed the positive benefit-risk profile of the treatment for prevention of stroke in patients with atrial fibrillation (AF)*.
On Friday 2nd November, the FDA published the results of a Mini-Sentinel assessment that indicated the bleeding rates associated with new use of Pradaxa® are not higher than those associated with new use of warfarin.1 With this analysis the FDA further confirmed the results demonstrated by the landmark 18,000-patient RE-LY® trial, upon which the treatment was approved. The announcement of the results follows the FDA’s U.S. label update in June this year. The U.S. label affirms superior reduction in ischemic and hemorrhagic stroke versus warfarin in patients with non-valvular atrial fibrillation.
The FDA Mini-Sentinel assessment evaluated new information about the risk of serious bleeding associated with use of the anticoagulants Pradaxa® and warfarin. The FDA investigated the rates of gastrointestinal bleeding and intracranial haemorrhage for new users of Pradaxa® compared to new users of warfarin. The assessment was undertaken using insurance claims and administrative data from the FDA’s Mini-Sentinel pilot of the Sentinel Initiative.
Specifically, the FDA states: "For the populations in the Mini-Sentinel data assessment, the combined incidence rate (ICH and GIH events** per 100,000 days at risk) was 1.8 to 2.6 times higher for new users of warfarin than for new users of Pradaxa®.”1
Further, "The FDA has not changed its recommendations regarding Pradaxa®. Pradaxa® provides an important health benefit when used as directed.”1
This follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on the renewal of the marketing authorisation for Pradaxa® in October.2
The CHMP’s recommendation for renewal of the marketing authorisation for the next five years supports the benefits that Pradaxa® has been delivering to patients since its first approval in March 2008. The recommendation was based upon the favourable risk-benefit profile of the treatment, confirmed by the CHMP following comprehensive evaluation and includes all licensed indications of the treatment.2
"We welcome the positive conclusions reached by both the EMA’s CHMP Committee and the FDA in relation to the risk-benefit profile of Pradaxa®,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The renewal of the marketing authorisation in Europe will reassure both healthcare professionals and patients of the benefit from this highly effective anticoagulant. Furthermore, the FDA’s assessment is a clear cut statement for Pradaxa®’s favourable safety profile, now demonstrated also in real-world clinical practice.”
Boehringer Ingelheim will present a wealth of latest data on Pradaxa® from 16 abstracts at the American Heart Association’s (AHA) Scientific Sessions in Los Angeles from 3-7 November 2012, including the first and only long-term safety and efficacy data of an oral anticoagulant, the results of the RELY-ABLE® study. The data reinforce Boehringer Ingelheim’s ongoing commitment to adding to the scientific body of evidence for Pradaxa® and the benefit of the treatment for stroke prevention in atrial fibrillation.
*The reconfirmation of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) includes both indications of Pradaxa®: for prevention of stroke in patients with atrial fibrillation and for prevention of venous thromboembolism.
**ICH and GIH= Intracranial hemorrhage (brain bleeding) and gastrointestinal hemorrhage (bleeds in pharynx, stomach, colon or rectum)
Please click on the link below for ‘Notes to Editors’ and ‘References’:
Boehringer Ingelheim GmbH
Media + PR
Phone: +49 6132 77 8271
More information: www.boehringer-ingelheim.com
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