Pfizer Inc. and Bristol-Myers Squibb Co.’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.
About 2.66 million people in the U.S. have atrial fibrillation, the most common type of irregular heart beat, 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.
Eliquis will provide another option for the prevention of blood clots and strokes, and the drug showed in clinical trials that it was more effective than warfarin, the FDA said in its statement. It is among a group of new blood thinners such as Boehringer Ingelheim GmbH’s Pradaxa and Johnson & Johnson and Bayer AG’s Xarelto, that are potential replacements for warfarin, which requires regular blood monitoring by doctors.
The new drugs carry some risk of bleeding, as does warfarin. Bleeding can happen in the stomach, under the surface of the skin, or most dangerously, in the brain.
The new blood thinners offer a better trade-off between bleeding and stroke-prevention, said Andrew Epstein, a professor of medicine at the University of Pennsylvania in Philadelphia. “One intracranial bleed is a small price for the great decrease in morbidity and mortality,” Epstein said in a telephone interview. “There ain’t any free lunch.”
Eliquis has been approved in Europe and Japan. Pfizer and Bristol-Myers also want to gain approval for use in clots elsewhere in the body, including the legs and lungs.