Health Canada approves PRADAX anticoagulant for stroke prevention in AF patients

PRADAX^™ is a long awaited alternative for a quarter of a million Canadians at high risk of stroke due to atrial fibrillation (AF)

Boehringer Ingelheim (Canada) Ltd. today announces that Health Canada has granted approval of PRADAX^™ (dabigatran etexilate), an oral anticoagulant for the prevention of stroke and systemic embolism in adults with atrial fibrillation in whom anticoagulation is appropriate. PRADAX^™ is the first innovative drug approved in Canada in more than two decades to reduce the risk of stroke in Canadians with atrial fibrillation.

PRADAX^™, at a dose of 150 mg twice daily, was shown to be superior to warfarin, the current standard of care, in reducing a patient's chance of suffering a stroke or systemic embolism (blood clot). As with all anticoagulants, bleeding is of concern but PRADAX^™ significantly reduced life threatening, intracranial and total bleeding compared to warfarin. PRADAX^™ is expected to offer patients much more freedom as it does not require ongoing blood tests and significantly reduces the costs associated with regular monitoring and doctor's visits. It also has no known food interactions and a low potential for interaction with other drugs.

"Dabigatran is a significant breakthrough in medicine. We have been waiting for a long time for an alternative to warfarin, our current standard treatment against stroke for patients with atrial fibrillation," says Dr. Stuart Connolly, Director, Division of Cardiology at The Population Health Research Institute, at McMaster University in Hamilton. "It is really great to finally have an alternative new treatment for our patients with atrial fibrillation which is not only safer and more effective than our current blood thinners, but also much easier to use. It is also important that many patients who were unsuitable for standard therapy will now have an effective agent that they can use to prevent stroke. The approval of dabigatran will transform the way we treat and manage atrial fibrillation patients at risk of stroke."

Atrial fibrillation, also known as an irregular heartbeat, affects up to 250,000 Canadians, and is a serious yet common heart condition that can lead to severe and debilitating strokes. Canadians with AF are at least five times more at risk of having a stroke and are twice as likely to die from one. In Canada, stroke is the leading cause of adult disability and the third leading cause of death with up to 15 per cent of strokes being caused by AF.

"Stroke and the resulting disability takes a toll on the patient and family. AF-related strokes tend to be much more severe and prevent survivors from carrying out normal everyday activities," said Dr. Mike Sharma, Deputy Director, Canadian Stroke Network and Director Regional Stroke Program, Ottawa Hospital, Civic Campus. "The costs related to stroke can put a big financial burden on patients' families, as well as the health-care system."

The health care costs for patients in the first six months after a stroke total more than $2.5 billion a year, with direct and indirect costs for each patient averaging $50,000 in the first six months following a stroke. People with non-disabling strokes spend up to $24,000 during the first six months and the costs for families can increase to over $100,000 for the most severely affected. Examples of stroke-related expenses to families include those associated with caregiving, transportation, and lost income.

President and CEO of Boehringer Ingelheim (Canada) Ltd, Dr. Ted Witek said that the company is pleased with the recent Canadian approval, noting: "The approval of PRADAX^™ in Canada marks a new era for stroke prevention in atrial fibrillation, and for the125-year history of Boehringer Ingelheim as a company. Key to Health Canada's decision was the RE-LY^® trial, and we proudly recognize that this global program was coordinated out of McMaster University in Hamilton, Ontario. PRADAX^™ will fulfill an unmet therapeutic need and improve the lives of many Canadian patients with atrial fibrillation."

Coinciding with the Health Canada approval of PRADAX™, the Canadian Cardiovascular Society (CCS) has released new guidelines on stroke prevention in atrial fibrillation, which contain guidance on the use of dabigatran etexilate. Based on the strength of the safety and efficacy profile of PRADAX™, the guidelines state that dabigatran is preferred over warfarin for overall stroke reduction, particularly the 150mg dose twice-daily.