FDA Green Lights Daiichi Sankyo's New Anti-Clotting Drug

January 9, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

Daiichi Sankyo Company today announced that the U.S. Food and Drug Administration (FDA) has approved Savaysa, also known as edoxaban, as a treatment to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF). Savaysa, is an oral, once-daily selective factor Xa-inhibitor, which functions as an anti-clotting drug.

Savaysa enters a crowded market as the fourth new oral anticoagulant introduced into the U.S. market, according to The Pharmaletter. Competitors include Boehringer Ingelheim’s Pradaxa (dabigatran), Bayer and Johnson & Johnson ’s Xarelto (rivaroxaban), and Bristol-Myers Squibb and Pfizer ’s Eliquis (apixaban).

“In patients with atrial fibrillation, anti-clotting drugs lower the risk of stroke by helping to prevent blood clots from forming in the heart,” Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, was quoted as saying in The Pharmaletter. He further stated, “it is important to have a variety of these types of drugs available as options for patients.”

“Savaysa is an important new anticoagulant in the U.S.,” said Glenn Gormley, senior executive officer and global head of research and development at Daiichi Sankyo. He noted that the clinical trials upon which the approval was based showed that Savaysa reduced “the risk of stroke and SE with significantly less major bleeding for patients with NVAF…versus warfarin, the most commonly prescribed anticoagulant.” Gormley also pointed out that Savaysa, “offers the convenience of once-daily dosing, no need for routine blood monitoring and the flexibility to be taken with or without a meal.”

The trials, referred to as ENGAGE AF-TIMI 48 and Hokusai-VTE studies, are the largest and longest single comparative global trials of a novel oral anticoagulant in patients with NVAF or VTE, according to the company. EGNAGE AF-TIMI involved 21,105 patients and Hokusai-VTE involved 8,292.

“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,” said Joji Nakayama, president and chief executive officer of Daiichi Sankyo Company. “We look forward to making Savaysa available to patients in the U.S. with NVAF and venous thromboembolism, two serious conditions that are expected to double in prevalence by mid-century.”

Savaysa was approved in Japan in September 2014. Daiichi Sankyo said the drug would likely be available in the U.S. as early as February 2015.