Boehringer’s Pradaxa recommended for expanded European licence
pharmafile | April 18, 2011 | News story | Sales and Marketing | Boehringer Ingelheim, CHMP, Pradaxa
Pradaxa is on course to expand its European licence with a recommendation from the CHMP for a new indication in atrial fibrillation (AF) for stroke prevention.
The regulatory advisers backed Pradaxa as treatment for the prevention of stroke and systemic embolism in adult patients with nonvalvular AF with one or more risk factors.
The drug has already been approved on a similar basis for patients with AF in 13 countries including Canada, Japan, South Korea, New Zealand, Israel and Malaysia.
Usually followed by approval, this amber light continues impressive progress for Boehringer Ingelheim’s drug, which last October trumped its rivals by being the first new oral anticoagulant to reach the US market in 50 years.
Small wonder that, at its annual press conference this month, Boehringer identified Pradaxa (dabigatran etexilate) as one of the cornerstones of its “new growth phase” as the manufacturer seeks to fill the gap left by patent expiries.
Boehringer has been steadily seeking to broaden its use from an original indication of preventing venous thrombo-embolism after hip and knee replacement surgery.
Klaus Dugi, Boehringer’s corporate senior vice president medicine, said: “When approved in the EU, dabigatran etexilate (150mg bid) will improve the lives of many patients by significantly reducing the risk of strokes compared to warfarin and avoid immense suffering for a vast proportion of them.”
In the RE-LY trial, this dose of Pradaxa reduced the risk of stroke and systemic embolism by 35% as well as significantly lowering the risk of intracranial bleeding compared to well controlled warfarin.
Up to three million people worldwide suffer strokes related to atrial fibrillation each year, and the novel, oral direct thrombin inhibitor is part of a new class of drugs – including Bayer’s Xarelto and Pfizer/BMS’s apixiban – seeking to replace warfarin.
Xarelto last year won the prestigious Prix Galien award for the most innovative drug and, like Pradaxa, is already sold in Europe to prevent clots after hip and knee operations.
Adam Hill
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