CHMP recommends Lixiana (edoxaban) for non-valvular AF, and deep vein thrombosis and pulmonary embolism-Daiichi Sankyo

The EU's CHMP has recommended approval of Lixiana (edoxaban), from Daiichi Sankyo, for the prevention of stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors. The CHMP also recommended approval of Lixiana for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. The two related conditions DVT and PE are collectively referred to as venous thromboembolism (VTE).

The recommendation is based on the data of the Phase III ENGAGE AF-TIMI 48 and Hokusai-VTE studies, respectively. In the ENGAGE AF-TIMI 48 study, once-daily edoxaban 60 mg demonstrated non-inferiority to well-managed warfarin for the primary efficacy endpoint of occurrence of stroke or SE in patients with NVAF (1.18% vs. 1.50% per year, respectively). In addition, once-daily edoxaban 60 mg demonstrated a significant 20% risk reduction of major bleeding in patients with NVAF compared to warfarin (2.75% vs. 3.43% per year, respectively).

In the Hokusai-VTE study, once-daily edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE (3.2% vs. 3.5% of patients, respectively). In addition, edoxaban demonstrated a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively).

Comment: There are already three drugs competing to reduce the dominance of warfarin - two other factor Xa inhibitors, Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Pfizer/BMS’s Eliquis (apixaban), and Boehringer Ingelheim’s oral thrombin inhibitor Pradaxa (dabigatran etexilate).The primary difference amongst Pradaxa, Eliquis, Xarleto and edoxaban is that Eliquis and edoxaban are once-daily pills, while Pradaxa and Xarelto are taken twice daily.