Daiichi Sankyo has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new label update for its drug Lixiana.
The proposed label update would provide guidance on the drug's use in patients undergoing transoesophageal echocardiography-guided and delayed cardioversion, a form of treatment used to restore a normal heart rhythm.
“Daiichi Sankyo's Lixiana has been recommended by the CHMP for a label update expanding its use among patients with atrial fibrillation undergoing cardioversion.“
This is based on results from the ENSURE-AF study, the largest prospective randomised clinical trial of an anticoagulant for cardioversion in patients with non-valvular atrial fibrillation, with a total of 2,199 patients enrolled.
Findings from this study supported the use of Lixiana as an effective and safe alternative to the best possible conventional treatment with enoxaparin and warfarin, with the drug's rapid onset of action allowing for prompt cardioversion.
Dr Wolfgang Zierhut, executive director of EU cardiovascular medical affairs, said: "Daiichi Sankyo is committed to supporting patients and physicians by advancing understanding of the efficacy and safety of Lixiana in different clinical settings, through studies such as ENSURE-AF."
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