Boehringer Ingelheim’s Pradaxa wins vote of confidence from regulators

Boehringer Ingelheim has announced that healthcare regulators in the US and EU have reaffirmed the health benefits and safety of its anticoagulation therapy Pradaxa.

The US Food and Drug Administration (FDA) and European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) have both reconfirmed the positive benefit-risk profile of the drug for the prevention of stroke in patients with atrial fibrillation.

Data from a study of bleeding rates associated with the treatment supported the FDA decision, while the CHMP ruling also covers the drug's venous thromboembolism indication.

The CHMP has therefore recommended that Pradaxa's European marketing authorisation be extended for an additional five years.

Professor Klaus Dugi, corporate senior vice-president for medicines at Boehringer Ingelheim, said: "The renewal of the marketing authorisation in Europe will reassure both, healthcare professionals and patients, of the benefit from this highly effective anticoagulant."

This comes after the company received an expanded EU approval last month for Trajenta, the diabetes therapy it has developed alongside partner Lilly.