Anti-Clotting Agent Launches in United States

Daiichi Sankyo today announced the US launch of edoxaban (Savaysa), a once-daily anti-clotting agent indicated for reducing the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF).

The selective factor Xa-inhibitor was also approved for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

The drug received FDA approval in January 2015 following clinical trials that demonstrated its safety and efficacy compared with warfarin.

“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,” said Howard Rutman, MD, vice president of medical affairs for Daiichi Sankyo, in a press release. “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.”

“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,” added Ken Keller, president of US commercial for Daiichi Sankyo.

Savaysa should not be used in NVAF patients with creatinine clearance levels >95 mL/min due to an increased risk of ischemic stroke compared with warfarin, according to the drug’s label.

The most common adverse events observed in trial participants treated with Savaysa were bleeding and anemia. Bleeding associated with anti-clotting medications such as Savaysa may be life-threatening.

Update (February 10, 2015): A safety comparison report published today by AdverseEvents suggested that Savaysa was not as safe as Bristol-Myers Squibb's anticoagulant drug, apixaban (Eliquis). The study found higher reporting rates for 20 of Savaysa's on-label adverse events compared with corresponding Eliquis side effects.