FDA Advisory Committee makes recommendation on Savaysa for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation
The FDA ( Food and Drug Administration ) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily Savaysa ( Edoxaban ) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events ( SEE ) in patients with non-valvular atrial fibrillation ( NVAF ).
The recommendations were provided after review of the ENGAGE AF-TIMI 48 study results, which were previously communicated at the 2013 American Heart Association Scientific Sessions.
The data demonstrated that once-daily Edoxaban met the primary efficacy endpoint of non-inferiority compared to Warfarin for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation, and demonstrated significantly less major bleeding compared to Warfarin, achieving superiority for the principal safety endpoint of major bleeding.
Daiichi Sankyo is currently seeking approval from the FDA for the 60 mg dosing regimen of Edoxaban ( with a dose reduction to 30 mg for patients with known factors such as renal impairment, low body weight or concomitant use of certain P-glycoprotein inhibitors that can potentially increase the risk of bleeding due to expected higher Edoxaban exposure ) for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation.
Daiichi Sankyo is also seeking approval of Edoxaban for the treatment and prevention of recurrence of symptomatic venous thromboembolism ( VTE ) based on the results from the Hokusai-VTE study, which is the single largest comparative trial of a novel oral anticoagulant in this patient population.
Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.
The global Edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 ( Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation ), which included nearly 30,000 patients combined.
The results from these trials form the basis of regulatory filings for Edoxaban for symptomatic venous thromboembolism ( VTE ) in patients with deep vein thrombosis and/or pulmonary embolism, and for the prevention of stroke in non-valvular atrial fibrillation, respectively. ( Xagena )
Source: Daiichi Sankyo, 2014