Boehringer Ingelheim’s Pradaxa receives SMC approval

Boehringer Ingelheim's Pradaxa therapy for stroke prevention among atrial fibrillation patients has been accepted for use by the Scottish Medicines Consortium (SMC).

The product, which was licensed in the EU for the prevention of stroke and systemic embolism in at-risk adult patients with nonvalvular atrial fibrillation, has been ratified for NHS Scotland use based on its strong performance in clinical trials.

Data from the phase III Re-ly trial showed its efficacy compared to warfarin among more than 18,000 patients enrolled in 44 countries across the world.

Pradaxa is the first new oral anticoagulant to be licensed for this indication in more than 50 years and could be an important new option for the treatment of atrial fibrillation, which is the UK's most common heart rhythm condition.

Professor Adrian Brady, a consultant cardiologist for the department of medical cardiology at Glasgow Royal Infirmary, said: "This is excellent news for eligible patients in Scotland who will now have access to Pradaxa, a new anticoagulant."

Last month, the company announced a new funding award for a number of global projects designed to help combat atrial fibrillation-related strokes, as part of its 1 Million 1 Mission initiative.