Daiichi Sankyo Company announced that Savaysa (edoxaban), an oral, once-daily selective factor Xa-inhibitor, is now commercially available in US pharmacies.

Savaysa was approved by the US Food and Drug Administration (FDA) on January 8, 2015 for the reduction in risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant. According to the US label, Savaysa should not be used in NVAF patients with creatinine clearance (CrCL) levels greater than 95 mL/min because in that population there is an increased risk of ischemic stroke compared to warfarin.1

“The availability of Savaysa provides appropriate patients and their physicians with a new anticoagulant that has been shown to reduce the risk of stroke and SE with significantly less major bleeding compared to warfarin in patients with NVAF and that treats venous thromboembolism with significantly less clinically relevant bleeding compared to warfarin,” says Howard Rutman, MD, vice president, medical affairs, Daiichi Sankyo, Inc. “It is important to have additional treatment options for these complex conditions with diverse patient populations, and it is good to know that new treatments like Savaysa are available to patients with NVAF or venous thromboembolism.”

“The availability of Savaysa now expands our cardiovascular-metabolic US product portfolio to seven FDA-approved treatments, reinforcing our longstanding commitment towards helping to address the needs of patients with cardiovascular diseases, including those with NVAF and venous thromboembolism,” said Ken Keller, president, US Commercial, Daiichi Sankyo, Inc. “We are proud to be able to provide these patients a new treatment option with a compelling safety and efficacy profile that offers the convenience of once-daily dosing, no need for routine blood monitoring and the flexibility to be taken with or without a meal.”

With the launch of Savaysa, Daiichi Sankyo has developed resources for physicians and patients to help ensure patients can begin and/or remain on Savaysa per physician instructions. The Savaysa Savings Plus program will include a reimbursement hotline to assist patients and prescribers who request help understanding the patient’s available coverage. Eligible patients who are prescribed Savaysa can enroll in a copay savings program and pay $4 per month through the Savaysa SAVINGS CARD. Vouchers will also be available to provide patients and doctors a way to try Savaysa at no cost to see if it is right for the patient. In addition, the Savaysa Patient Assistance Program will offer assistance to qualified individuals, providing free product to eligible patients who are prescribed Savaysa, are uninsured and are unable to identify alternative payment sources.

The approval of Savaysa in the US is based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE trials, the largest and longest single comparative global trials of a novel oral anticoagulant with NVAF or VTE, involving 21,105 and 8,292 patients, respectively.

In ENGAGE AF-TIMI 48, Savaysa demonstrated significantly less major bleeding in patients with NVAF in the overall study population (hazard ratio [HR], 0.80; 95 per cent confidence interval [CI], 0.70 to 0.91, p<0.001) and was non-inferior to warfarin for the primary efficacy endpoint of stroke or SE. In the indicated NVAF patient population in the US (patients with CrCL = 95 mL/min), the rate of stroke and SE was 1.2 per cent per year for Savaysa versus 1.8 per cent per year for warfarin (HR, 0.68; 95 per cent CI, 0.55 to 0.84). Consistent with the overall results, Savaysa also demonstrated fewer major bleeding events compared to warfarin in the indicated NVAF population, as well as lower rates of intracranial hemorrhage (0.5 per cent per year for Savaysa and 1.0 per cent per year for warfarin) and fatal bleeding (0.2 per cent per year for Savaysa and 0.4 per cent per year for warfarin), but higher rates of major GI bleeding (1.8 per cent per year for Savaysa and 1.3 per cent per year for warfarin).

In Hokusai-VTE, Savaysa was shown to be non-inferior to warfarin for the primary endpoint of symptomatic recurrent VTE, with a significant 19 per cent reduction in clinically relevant bleeding compared to warfarin (8.5 per cent vs. 10.3 per cent; HR, 0.81; 95 per cent CI, 0.71 to 0.94, p=0.004) in patients with DVT or PE, following 5 to 10 days of initial therapy with a parenteral anticoagulant.

The most common side effects observed in ENGAGE AF-TIMI 48 and Hokusai-VTE clinical trial participants were bleeding and anemia. Savaysa increases the risk of bleeding and can cause serious and potentially fatal bleeding.