First warfarin replacement approved

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval. Warfarin was approved in 1954.

Replacement drugs for warfarin are considered blockbusters because of the critical need, particularly as the aging population becomes more vulnerable to atrial fibrillation and other conditions that can cause blood clots. Atrial fibrillation affects more than 2 million Americans.

Dabigatran is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of the drug were studied in a clinical trial comparing dabigatran etexilate with the anticoagulant warfarin. In the trial, patients taking dabigatran had fewer strokes than those who took warfarin.

“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, in an FDA press release.

Added Formulary Clinical Editor David Calabrese, RPH, MHP, “Given the significant complexities associated with warfarin therapy in patients with atrial fibrillation, dabigatran may represent a pivotal advancement in the care of individuals with this condition.

“From a managed care perspective, the employment of thoughtful and judicious clinical and pharmacoeconomic assessment will be vital toward ensuring appropriate positioning of this important new therapy, as well as others soon to follow within this therapeutic area,” said Calabrese, chief clinical officer, MedMetrics Health Partners, Worcester, Mass.

Pradaxa will be available in 75-mg and 150-mg capsules.