Tags: FDA | approves | new | anticoagulants | Eliquis | traditional | warfin

FDA OKs New Blood Thinner Med

Monday, 31 Dec 2012 07:52 AM


Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY)’s blood thinner Eliquis was approved by U.S. regulators after more than a year of review, giving the companies a new potential blockbuster heart drug.
Eliquis was cleared by the Food and Drug Administration for the prevention of blood clots that develop in patients with the heart rhythm disorder atrial fibrillation, the agency said today in a statement. The approval comes three months before the FDA’s most-recent March deadline for a ruling on the drug, allowing the two New York-based companies to start sales sooner.
“The new anticoagulants are really exciting developments,” William Zoghbi, president of the American College of Cardiology, said in a telephone interview. “They address some of the concerns that traditional warfarin has offered.” Warfarin is the half-century-old drug that has been the standard of care before new medicines like Eliquis.
The government’s sign-off ends several setbacks in the efforts by Pfizer and Bristol-Myers to win sales clearance for the blood thinner. The FDA delayed approval in March 2012 and rejected the therapy in June, saying it needed more data from the companies’ clinical trials. Pfizer, the world’s largest drugmaker, and Bristol-Myers will split sales, which may total $5.2 billion by 2020, Catherine Arnold, an analyst at Credit Suisse in New York, said in a note to clients.
Pfizer shares rose less than 1 percent in extended trading to $24.99 at 4:57 p.m. New York time, after closing at $24.89. Bristol-Myers rose 1.9 percent after closing at $31.90.
Common Condition
About 2.66 million people in the U.S. have atrial fibrillation, the most common type of irregular heartbeat, according to the Centers for Disease Control and Prevention in Atlanta. The disease becomes more common with age. Patients have a higher risk of blood clots, which can cause strokes, and of heart failure.



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A new blood thinner called Eliquis has been approved by the FDA anticoagulants traditional warfin and has the potential to be a blockbuster drug.
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Monday, 31 Dec 2012 07:52 AM
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