The U.S. Food and Drug Administration approved Pradaxa, formulated in capsules by Boehringer Ingelheim Pharmaceuticals Inc. to prevent stroke in patients with abnormal heart rhythm.
Boehringer Ingelheim is among the largest employers in Fairfield County, with its U.S. headquarters in Ridgefield where it had more than 2,500 employees at last report.
Atrial fibrillation, which affects about 2.3 million Americans, involves very fast and uncoordinated contractions of the heart”™s two upper heart chambers, and is one of the most common types of abnormal heart rhythm. Boehringer Ingelheim says atrial fibrillation increases the risk of stroke by nearly five times, and is associated with up to 15 percent of all strokes in the United States.
“For many years, physicians have been searching for new options to reduce the risk of stroke faced by millions of patients with atrial fibrillation,” said Dr. Jonathan Halperin, director of clinical cardiology services at the Mount Sinai Medical Center in New York, in a statement. “Many of these patients are either not receiving anticoagulation therapy or are taking it sub-optimally, placing them at risk for stroke or major bleeding.”
The drug could generate $1.3 billion in revenue for Boehringer Ingelheim by the year 2018, according to Decision Resources Inc., a pharmaceutical market research company based in Burlington, Mass. In 2009, Boehringer Ingelheim posted global sales of $17.7 billion.
In September, Boehringer Ingelheim enlisted daytime TV star Susan Lucci and husband Helmut Huber to help raise awareness of the condition, with Huber diagnosed with atrial defibrillation.
“This is a special moment which exemplifies innovation in modern medicine,” said Albert Ros, CEO of Boehringer Ingelheim Pharmaceuticals, in prepared comments. “This approval marks a proud moment in our company”™s 125-year history.”
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 a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin, which can have adverse interactions with other drugs and foods containing vitamin K, like spinach and broccoli.
“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 Dr. Norman Stockbridge, director of the division of cardiovascular and renal products in the FDA”™s Center for Drug Evaluation and Research, in a written statement. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”
The FDA stated that patients taking Pradaxa also reported some side effects, including gastrointestinal symptoms like stomach pain, nausea and heartburn; and life-threatening bleeding, as the case with other approved anti-clotting drugs. Pradaxa was approved with a medication guide that informs patients of the risk of serious bleeding. The guide will be distributed each time a patient fills a prescription for the medication.
Boehringer Ingelheim conducted a clinical trial of the treatment involving more than 18,000 patients.
Several other pharmaceutical companies are racing the market with their own treatments for the disorder. In 2009, FDA approved Paris-based Senofi-Avantis”™ Multaq tablets; with Ortho-McNeil-Janssen Pharmaceuticals Inc., Bayer is readying its Xarelto drug candidate for FDA approval, as are Bristol-Myers Squibb and Pfizer Inc. with their Apixaban drug candidate. Pfizer is based in New York City and has major installations in Groton and Pearl River, N.Y.
