Daiichi Sankyo’s oral anticoagulant edoxaban was able to prevent strokes and blood clots in patients with atrial fibrillation (AF) equally as well as warfarin treatment, according to a massive new study.
The pharma company said the Factor Xa inhibitor – which is already marketed in Japan as Lixiana to prevent venous thromboembolism (VTE) in patients undergoing orthopaedic surgeries – was also significantly less likely to cause bleeding complications than warfarin.
The 21,000-patient ENGAGE AF-TIMI 48 trial was presented at the American Heart Association (AHA) and tested two doses of edoxaban – 30mg and 60mg once-daily – finding both were both safer than the comparator drug although the lower dose was not quite as effective at reducing ischaemic strokes.
Both doses of edoxaban were more effective than warfarin at reducing cardiovascular mortality and haemorrhagic stroke, according to the clinical investigators who have just published their findings in the New England Journal of Medicine.
Intriguingly, the study protocol also allowed edoxaban dose reductions from 60mg to 30mg in patients expected to achieve elevated blood levels of the drug because of factors such as renal dysfunction, low body weight or concomitant use of certain drugs. Around 25 per cent of patients needed dose reductions but there was no impact on the efficacy of the drug.
Earlier this year Daiichi Sankyo reported data from a phase III trial of edoxaban for treatment and prevention of recurrent symptomatic VTE, saying it intends to file for approval of edoxaban in this indication by the first quarter of 2014 in the US, Europe and Japan.
The data in AF will allow the drug to compete on an equal footing with other new anticoagulants that have reached the market in recent years, including Boehringer Ingelheim’s direct thrombin inhibitor Pradaxa (dabigatran) and two other Factor Xa inhibitors, Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) and Bayer’s Xarelto (rivaroxaban).
Edoxaban will launch later than its competitors but is still expected to make an impact given the clear superiority over warfarin on bleeding – shared with all the other three new entrants – as well as the patient-specific dosing which could be viewed as enhancing its safety profile. Some analysts have suggested the new candidate could make $5bn or more in peak annual sales.