Boehringer Ingelheim’s Pradaxa receives new NICE approval

Boehringer Ingelheim has announced that its novel oral anticoagulant Pradaxa has been approved in a new indication by the National Institute for Health and Care Excellence (NICE).

The drug has been authorised for NHS use in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for the prevention of both conditions, in adult patients. The decision applies to NHS patients in both England and Wales.

Results from four phase III clinical trials involving more than 9,000 patients that demonstrated the efficacy of Pradaxa in the treatment of DVT and PE, and the prevention of recurrence compared to warfarin or placebo, helped to support this decision.

The NICE guidance mirrors the positive opinion issued by the Scottish Medicines Consortium in October 2014.

Charles de Wet, medical director for Boehringer Ingelheim in the UK and Ireland, said: "This news broadens the ways in which Pradaxa can be used allowing patients to have more choices. This is great news for patients and will provide a welcome additional option for the management of DVT/PE."

Earlier this month, the company commenced a new clinical trial of Pradaxa, assessing the anticoagulant therapy as a stroke prevention aid.