Pradaxa sNDA filed with FDA for DVT and PE in patients after hip replacement-Boehringer

Boehringer has filed a supplemental New Drug Application with the FDA for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery. The submission is based on the results of two randomized, double-blind, phase III trials, RE-NOVATE and RE-NOVATE II, which compared the efficacy and safety of Pradaxa to enoxaparin in preventing venous thromboembolism (VTE) and death in patients undergoing total hip replacement surgery.

The results showed patients taking Pradaxa 220 mg had a lower composite total of VTE (VTE comprises DVT and PE) and all-cause death (6.0 percent) than those on Pradaxa 150 mg (8.6 percent) and on enoxaparin 40 mg (6.7 percent). There was no significant difference in the rates of major bleeding among all treatment groups: 2.0 percent for Pradaxa 220 mg, 1.3 percent for Pradaxa 150 mg and 1.6 percent for enoxaparin 40 mg. The most common adverse events were gastrointestinal disorders, with similar frequencies in all treatment groups (Pradaxa 220 mg, 44.2 percent; Pradaxa 150 mg, 44.0 percent; enoxaparin 40 mg, 44.8 percent).

In RE-NOVATE II, results showed the composite total of VTE and all-cause death occurred in 7.7 percent of patients in the Pradaxa group vs. 8.8 percent of patients in the enoxaparin group. There was no difference in major bleeding rates between the two treatments (1.4 percent for patients on Pradaxa and 0.9 percent for patients on enoxaparin).

Comment:Pradaxa is facing strong competition, including Eliquis (apixaban) from BMS/Pfizer, while other treatments available to treat DVT and/or PE include: warfarin, heparin,and Xarelto (rivaroxaban) from Bayer/Johnson & Johnson.