Daiichi Sankyo launches new formulation of LIXIANA® 60 mg Tablets (edoxaban) in Japan

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has launched a new formulation of LIXIANA^®60 mg Tablets (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban, approval to market: September 26, 2014; NHI drug price listing: November 25, 2014) in Japan for the recently approved indications: the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)].

LIXIANA was approved in Japan in April 2011, for the prevention of VTE after major orthopedic surgery and was launched in July 2011.¹ LIXIANA was also approved in Japan in September 2014 for the prevention of ischemic stroke and systemic embolism in patients with NVAF and for the treatment and recurrence prevention of VTE. ² Daiichi Sankyo has also filed for approval of once-daily edoxaban in both the U.S. and EU for the reduction in risk of stroke in NVAF and for symptomatic VTE in patients with DVT and/or PE.^3,4

References

1. Daiichi Sankyo press release – Daiichi Sankyo launches LIXIANA® (edoxaban), a direct oral factor Xa inhibitor, in Japan for the prevention of venous thromboembolism after major orthopaedic surgery. 19 July 2011. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/
   detail/005784.html [Last accessed: December 2014].
2. Daiichi Sankyo press release – Daiichi Sankyo Receives Approval for Additional Indications of LIXIANA® (edoxaban) in Japan. 26 September 2014. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006189.html [Last accessed: December 2014].
3. Daiichi Sankyo press release – Daiichi Sankyo Submits SAVAYSA^TM (edoxaban) Tablets New Drug Application to the U.S. FDA for Once-Daily Use for Stroke Risk Reduction in Atrial Fibrillation and for the Treatment and Prevention of Recurrence of Venous Thromboembolism. 9 January 2014. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006065.html [Last accessed: December 2014].
4. Daiichi Sankyo press release – Daiichi Sankyo Submits Edoxaban Marketing Authorization Application to the EMA for Once-Daily Use for Stroke Prevention in Atrial Fibrillation and for the Treatment and Prevention of Recurrence of Venous Thromboembolism. 7 January 2014. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006062.html. [Last accessed: December 2014].