One-Daily Anti-Clotting Drug Approved for Reduction of Stroke Risk

A new anti-clotting drug to reduce the risk of stroke and dangerous blood clot in patients with non-valvular atrial fibrillation (NVAF) was approved by the FDA on Thursday.

The once-daily drug Savaysa by the Daiichi Sankyo Company, Limited, is expected to be commercially available in the US in February 2015, according to the company. In September 2014, the drug was approved in Japan for NVAF and venous thromboembolism (VTE) indications.

The FDA has also approved Savaysa to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an injection or infusion anti-clotting drug for 5 to 10 days.

“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, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “It is important to have a variety of these types of drugs available as options for patients.”

A clinical trial of 21,105 patients with atrial fibrillation not caused by cardiac valve disease found a higher dose of Savaysa showed results similar to warfarin for the reduction in the risk of stroke while demonstrating significantly less major bleeding than warfarin.

The drug is less effective in atrial fibrillation patients with a creatinine clearance greater than 95 mL/min because of an increased risk of stroke.

“Savaysa is an important new anticoagulant in the US and in the ENGAGE AF-TIMI 48 trial, Savaysa has been shown to reduce the risk of stroke and [systemic embolism] with significantly less major bleeding for patients with NVAF, and in the Hokusai-VTE trial, to treat DVT and PE with significantly less clinically relevant bleeding versus warfarin, the most commonly prescribed anticoagulant,” said Glenn Gormley, MD, PhD, senior executive officer and global head of R&D of Daiichi Sankyo Company, and limited and executive chairman and president of Daiichi Sankyo, Inc, said in a statement. “In addition, 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.”