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news.The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Japan-based Daiichi Sankyo's Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, to prevent stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors.
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Additionally, the CHMP has recommended approval of Lixiana to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as to prevent recurrent DVT and PE in adults.
Both DVT and PE, which have related conditions, are collectively referred to as venous thromboembolism (VTE).
Daiichi Sankyo Company R&D senior executive officer and global head and Daiichi Sankyo Inc executive chairman and president Glenn Gormley said: "The CHMP recommendation to approve once-daily edoxaban for the NVAF and VTE indications is an important milestone for our company.
"The European regulatory committee has recognised the positive benefit-risk profile of the 60mg dosing regimen (with a dose reduction to 30mg in selected patients with creatinine clearance (CrCL) 15-50mL/min, body weight = 60kg, or concomitant use of certain P-glycoprotein (P-gp) inhibitors)."
The CHMP positive opinion to approve once-daily edoxaban for the prevention of stroke and SE in adults with NVAF with one or more risk factors as well as to treat and prevent recurrent VTE is based on the data of the Phase III ENGAGE AF-TIMI 48 and Hokusai-VTE trials, respectively.
In the ENGAGE AF-TIMI 48 trial, once-daily edoxaban 60mg showed non-inferiority to well-managed warfarin for the primary efficacy endpoint of occurrence of stroke or SE in patients with NVAF.
The company said that in the Hokusai-VTE study, once-daily edoxaban 60mg was non-inferior to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE.