Boehringer’s Pradaxa Gains Additional European Indication

June 6, 2014

Boehringer Ingelheim announced Friday that the European Commission had approved Pradaxa (dabigatran etexilate) to treat and prevent the recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).

The FDA approved Pradaxa for the treatment of DVT and PE patients earlier this year.
The approval by the EC comes on the heels of a positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency, and is based on results from three phase III clinical trials that established the efficacy of Pradaxa, the German drugmaker said.

Additionally, results from a fourth study demonstrated a reduction of 92 percent in the risk of recurrent blood clots in patients who received Pradaxa compared to placebo. Safety data demonstrated that DVT or PE patients receiving Pradaxa had noticeably lower rates of bleeding compared with those on warfarin, leading to a good overall safety profile, the company said.

Pradaxa has the more clinical trial experience in DVT and PE patients than any other novel oral anticoagulant, BI noted.

DVT and PE can be very dangerous — nearly one in three PE patients dies within three months and 40 percent of patients suffer a repeat blood clot within 10 years of the first one.

The drug also has EU licensure for the primary prevention of venous thromboembolism, a collective term for DVT and PE, in patients who have undergone total knee or hip replacement surgery, BI said. — Kellen Owings

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