Daiichi Sankyo anticoagulant gains EU label boost

The product is currently a distant fourth in the lucrative novel oral anticoagulant market, trailing behind Boehringer Ingelheim’s Pradaxa , BMS/Pfizer’s Eliquis, and Bayer’s market leader Xarelto.

The Japanese company is nevertheless undertaking further studies of the drug in a number of niche settings to boost its use in markets around the world.

The company welcomed the CHMP recommendation in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.

Cardioversion is a procedure used to restore normal, regular heart rhythm in atrial fibrillation patients. Due to an associated risk of thrombotic events such as stroke, guidelines recommend anticoagulation before and after the procedure.

Lixiana is now the only medicine in its class with specific label guidance for early cardioversion within two hours after an initial intake in the TEE-guided approach.

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 Lixiana with Lixiana/warfarin.

Data support the use of Lixiana as an effective and well tolerated alternative to the best possible conventional clinical optimal treatment with enoxaparin and warfarin.

Lixiana’s rapid onset of action allows for prompt cardioversion in the TEE-guided approach as early as two hours after intake, helping to avoid delays or postponements of the procedure.

The primary efficacy endpoint of the ENSURE AF study was a composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality, which occurred in five patients in the edoxaban 60/30 mg arm versus 11 in the enoxaparin-warfarin arm.

The primary safety endpoint was major and clinically relevant non-major bleedings (CRNM), which occurred in 16 patients in the edoxaban arm versus 11 patients in the enoxaparin-warfarin arm. The difference between the treatment arms was statistically non-significant.

Event rates of thromboembolism and major and CRNM bleedings were low in the edoxaban and exceptionally well-controlled warfarin arms. There was no difference between the TEE-guided approach and the delayed cardioversion setting.