Boehringer Ingelheim’s anti-blood clotting drug Pradaxa has been approved for treating and preventing potentially-fatal blood clots in the legs and lungs.

Pradaxa (dabigatran) works as a blood thinner and is approved by the National Institute for Health and Clinical Excellent (NICE) for the prevention of strokes and systemic embolism in patients with irregular heart rhythm (atrial fibrillation) – although the watchdog initially turned the drug down on cost-effectiveness grounds.

Under the new indication, Pradaxa is licensed to treat deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE) if the blood clot travels from the legs to the lungs. Such blood clots can result in venous ulceration and chronic pain, swelling and skin changes in the affected limb which can have a significant impact on quality of life.

Pradaxa is one of three treatments including Bayer’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), that are being touted as more convenient alternatives to the 50-year old generic blood thinner warfarin.

“For many people, using warfarin can be difficult because of the need for frequent tests to see if the blood is clotting properly, and having to adjust the dose of the drug if it is not,” said Professor Carole Longson, NICE Health Technology Evaluation Centre director.

“The Appraisal Committee felt that dabigatran represents a potential benefit for many people who have had a DVT or PE, particularly those who have risk factors for recurrence of a blood clot and who therefore need longer term treatment. We are pleased, therefore, to be able to recommend dabigatran as a cost-effective option for treating DVT and PE and preventing further episodes in adults.”