EU CHMP recommends approval of label update for Lixiana (edoxaban) for cardioversion in patients with NVAF- Daiichi Sankyo

Daiichi Sankyo Europe announced that the European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for the company's oral, once-daily direct factor Xa-inhibitor Lixiana (edoxaban), to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion (treatment to restore a normal heart rhythm). The label update is based on results from the ENSURE-AF study, the largest, prospective randomised clinical trial of an anticoagulant for cardioversion in patients with NVAF.

The study enrolled 2,199 patients, and compared once-daily edoxaban with enoxaparin/warfarin with a median time in therapeutic range (INR 2-3) of 70.8 %. These data support the use of edoxaban as an effective and well tolerated alternative to the best possible conventional clinical optimal treatment with enoxaparin and warfarin. Edoxaban's rapid onset of action allows for prompt cardioversion in the TEE-guided approach as early as two hours after edoxaban intake, helping to avoid delays or postponements of the procedure. This label update makes edoxaban the only NOAC with specific label guidance for early cardioversion within two hours after edoxaban intake in the TEE-guided approach.

Comment: Cardioversion is a procedure used to restore normal, regular heart rhythm in AF patients. Due to an associated risk of thrombotic events such as stroke, guidelines recommend anticoagulation before and after the procedure. The delayed onset of action and fluctuations in INR associated with VKA treatments such as warfarin, can result in costly and inconvenient delays to cardioversion in patients. Initial treatment with enoxaparin (followed by overlapping VKA treatment) until the VKA reaches the therapeutic range of INR 2-3, represents the best possible conventional treatment.