FDA Okays Boehringer’s Pradaxa
The German drug manufacturer, Boehringer Ingelheim, has received approval from the Food and Drug Administration for its blood thinner drug.
The drug, Pradaxa, is used for preventing strokes and blood clots in patients with an abnormal heart beat.
The drug is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting.
"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, director of the FDA's division of cardiovascular and renal products in a news release.
Warfarin has been the treatment of choice for people at high risk of stroke due to atrial fibrillation but researxchers have found the drug interacts badly with food and other medicines and has a high risk of bleeding and patients on the drug are required to be regularly monitored.
A clinical trial comparing Warfarin was designed to study the safety and efficacy of Pradaxa.
The study results showed that patients taking Pradaxa had fewer strokes than those who took Warfarin
According to Boehringer, currently approximately 2.3 million Americans have atrial fibrillation with the prevalence expected to grow to 5.6 million by 2050 as the population ages.
Pradaxa will be available in 75 milligram and 150 milligram capsules.