Boehringer Ingelheim’s Pradaxa approved in more than 100 countries

Boehringer Ingelheim has announced that its innovative anticoagulant Pradaxa has now been approved in more than 100 countries.

The Jordan Food and Drug Administration has become the 100th regulatory body to approve the therapy for the prevention of stroke and systemic embolism for adult patients with non-valvular atrial fibrillation, the most common sustained heart rhythm condition.

Pradaxa became the first novel anticoagulant ratified for stroke prevention in patients with atrial fibrillation in October 2010 and has since received a continuous flow of regulatory authorisations all across the world.

It also offers the most robust clinical dataset and a greater body of real-world experience for stroke prevention in atrial fibrillation than any of the novel oral anticoagulants available on the market.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "Passing the landmark 100th approval of Pradaxa for stroke prevention and with still more on the horizon, we come close to saying that this novel treatment can benefit patients around the world."

The drug has accrued more than two million patient-years of experience in all licensed indications globally, with 12 company-sponsored trials of the compound currently in progress.