FDA approves Pradaxa for stroke prevention in a-fib patients

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CT images in a patient with left hemiparesis. Image source: Michael H. Lev, MD, and Angelos Konstas, MD, Massachusetts General Hospital.

The has approved dabigatran etexilate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) for the prevention of stroke and blood clots in patients with non-valvular atrial fibrillation, permitting the first pharmaceutical alternative to warfarin on the U.S. market.

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in the 18,113-patient RE-LY trial, comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

In late September, the FDA’s Cardiovascular and Renal Drug advisory committee has unanimously voted nine to zero in favor of Pradaxa.

“People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”

As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa, according to the FDA. Gastrointestinal symptoms, including dyspepsia, stomach pain, nausea, heartburn and bloating also were reported.

Pradaxa will be available in the U.S. in 75 mg and 150 mg capsules.

Atrial fibrillation, affecting more than two million Americans, involves very fast and uncoordinated contractions of the heart’s two upper atria, and is one of the most common types of abnormal heart rhythm.