Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The UK National Institute for Health and Care Excellence (NICE) has issued its final recommendation for Daiichi Sankyo’s Lixiana (edoxaban) to prevent stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).
Subscribe to our email newsletter
Edoxaban is an oral, once-daily, direct factor Xa inhibitor, which is one of the key parts responsible for blood clotting.
Under the ENGAGE AF-TIMI 48 global phase 3 study, Daiichi Sankyo investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with NVAF.
Edoxaban demonstrated non-inferiority for stroke or SE and was identified to be superior for the principal safety endpoint of major bleeding in comparison to warfarin.
The NICE committee accepted the limitations of warfarin therapy and the considerable impact it may have on people who take it, and recognized the possible benefits of edoxaban for people with NVAF.
It concluded that edoxaban was as clinically effective as warfarin for the primary efficacy outcome of reducing stroke (ischaemic and haemorrhagic) and systemic embolism, and had about half the rate of haemorrhagic stroke events compared to warfarin.
The NICE recommendation follows European marketing authorisation to the drug for two indiactions.
Daiichi Sankyo UK managing director Simon Clough said: "We are very pleased to be able to offer patients and doctors in England and Wales a new convenient alternative in the treatment armoury against AF-related illness.
"NICE has recognised an unmet clinical need among patients with AF and this recommendation confirms the value of LIXIANA, which combines convenience and safety compared to well managed warfarin with features that patients and physicians appreciate."