UK's NICE asks for more info on Boehringer's Pradaxa; backs Novartis' Tasigna but not Glivec or B-MS Sprycel for leukemia

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is asking independent German drug major Boehringer Ingelheim for more information on its product dabigatran Pradaxa) (dabigatran), its new drug for the prevention of stroke and systemic embolism in people with atrial fibrillation.

People with AF are at higher risk of developing blood clots and subsequent stroke - however, the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy (eg, warfarin), said the NICE is a preliminary recommendation.

Dabigatran has a UK marketing authorization for the prevention of stroke and systemic embolism in patients aged 75 years and over with non-valvular atrial fibrillation who have had a previous stroke, transient ischemic attack or systemic embolism, and/or left ventricular ejection fraction below 40%, and/or symptomatic heart failure of New York Heart Association (NYHA) Class 2 or above. Dabigatran also has a UK marketing authorization for people with AF aged 65 years or over who have diabetes, coronary heart disease or hypertension.