A Food and Drug Administration panel unanimously recommended Monday that the FDA approve Boehringer Ingelheim GmbH's blood-thinning drug Pradaxa. The move likely places the company as the first to get a new type of drug on the U.S. market to prevent strokes in patients with irregular heart rhythms.
Pradaxa and similar drugs in development are anticoagulants designed to prevent the formation of blood clots. The drugs aim to replace the widely used anticoagulant warfarin, sold under the brand name Coumadin, which was approved in 1954.
Warfarin is difficult to use and reacts with many other drugs and some foods. Pradaxa, also known by its generic name dabigatran, is approved outside the U.S. to prevent blood clots in patients undergoing knee or hip replacement surgery.
The FDA's cardiovascular and renal drugs advisory committee voted 9 to 0 in favor of approving dabigatran to reduce the risk of stroke and blood clots in patients with atrial fibrillation. The FDA usually follows the advice of its panels and is expected to make a decision by about Oct. 19.
Atrial fibrillation, or an irregular heart beat, puts people at higher risk of developing blood clots, which can be fatal if they travel to the lungs or the brain where they can cause a stroke.
Several companies are racing to develop new anticlotting drugs, for which Barclays has estimated the market could reach $12 billion by 2021. Bayer AG has teamed up with Johnson & Johnson to gain FDA approval of a similar drug, rivaroxaban. In 2009, an FDA advisory panel recommended rivaroxaban be approved for short-term use in patients undergoing knee or hip replacements. The FDA hasn't approved the drug and asked Bayer for more information.
Bristol-Myers Squibb Co. and Pfizer Inc. are co-developing apixaban. Merck & Co. is developing a product known as betrixaban with closely held Portola Inc. Also, Daiichi Sankyo Co. is developing a drug called edoxaban.
Pradaxa and similar drugs in development are anticoagulants designed to prevent the formation of blood clots. The drugs aim to replace the widely used anticoagulant warfarin, sold under the brand name Coumadin, which was approved in 1954.
Warfarin is difficult to use and reacts with many other drugs and some foods. Pradaxa, also known by its generic name dabigatran, is approved outside the U.S. to prevent blood clots in patients undergoing knee or hip replacement surgery.
The FDA's cardiovascular and renal drugs advisory committee voted 9 to 0 in favor of approving dabigatran to reduce the risk of stroke and blood clots in patients with atrial fibrillation. The FDA usually follows the advice of its panels and is expected to make a decision by about Oct. 19.
Atrial fibrillation, or an irregular heart beat, puts people at higher risk of developing blood clots, which can be fatal if they travel to the lungs or the brain where they can cause a stroke.
Several companies are racing to develop new anticlotting drugs, for which Barclays has estimated the market could reach $12 billion by 2021. Bayer AG has teamed up with Johnson & Johnson to gain FDA approval of a similar drug, rivaroxaban. In 2009, an FDA advisory panel recommended rivaroxaban be approved for short-term use in patients undergoing knee or hip replacements. The FDA hasn't approved the drug and asked Bayer for more information.
Bristol-Myers Squibb Co. and Pfizer Inc. are co-developing apixaban. Merck & Co. is developing a product known as betrixaban with closely held Portola Inc. Also, Daiichi Sankyo Co. is developing a drug called edoxaban.
**Published in "The Wall Street Journal"
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