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Daiichi Sankyo’s anti-clotting drug Savaysa gets FDA approval

Japan-based Daiichi Sankyo has received approval from the US food and Drug Administration (FDA) for its anti-clotting drug, Savaysa (edoxaban tablets).

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Savaysa is an oral, once-daily selective factor Xa-inhibitor developed to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).

Daiichi Sankyo representative director, president and chief executive officer Joji Nakayama said: "The approval of Savaysa demonstrates our commitment to providing new treatment options for cardiovascular diseases with significant unmet needs and reinforces our leadership in factor Xa-inhibition research, which began more than 30 years ago.

"We look forward to making Savaysa available to patients in the US with NVAF and venous thromboembolism, two serious conditions that are expected to double in prevalence by mid-century."

The approval was granted based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies of a new oral anticoagulant in patients with NVAF or VTE, involving 21,105 and 8,292 patients, respectively.

In ENGAGE AF-TIMI 48, the drug was non-inferior to warfarin in the overall trial population for the primary efficacy endpoint of stroke or SE.

Savaysa is not indicated for use in NVAF patients with creatinine clearance (CrCL) levels greater than 95mL/min due to chances of an increased risk of ischemic stroke compared to warfarin.

In 77% of the patients with CrCL less than or equal to 95mL/min, Savaysa 60mg (30mg dose reduced) reduced the risk of stroke and SE compared to warfarin, and the rates of cardiovascular death with Savaysa and warfarin were 2.95% per year vs. 3.59% per year, respectively.

Savaysa was also approved by the FDA to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) following five to ten days of initial therapy with a parenteral anticoagulant.


Image: Savaysa’s approval was based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.