NEW YORK (AP) -- Drugmaker Pfizer said Friday that European regulators have approved its highly-anticipated blood thinner Eliquis to prevent blood clots in patients who have had hip or knee replacement surgery.
The approval by the European commission means the drug, known as apixaban, will be available in the 27 countries of the European Union. Pfizer Inc. co-developed the drug with Bristol-Myers Squibb, which will share the profits.
The drug was approved based on two studies that showed better outcomes for patients taking twice-daily Eliquis rather than receiving an injection of the typical current treatment. Bleeding side effects were approximately the same between the two groups. All patients studied had undergone orthopedic surgery to replace a knee or hip, a procedure that raises the risk of blood clots.
Eliquis has been touted as a potential blockbuster drug for its ability to prevent blood clots without the bleeding side effects of older drugs like warfarin. However, last year the companies had to halt a 10,000-patient study of the drug in people with a history of heart disease after an unexpected number of bleeding side effects.
Apixaban works by blocking a clotting protein called factor Xa, which is part of the clotting reaction. That is in contrast to other blood thinners, which work by preventing platelets from sticking together.
The drug is not available in the U.S., though Pfizer and Bristol-Myers plan to submit it to the Food and Drug Administration later this year. The companies are seeking approval to prevent stroke in patients with a type of heart defect.
The approval by the European commission means the drug, known as apixaban, will be available in the 27 countries of the European Union. Pfizer Inc. co-developed the drug with Bristol-Myers Squibb, which will share the profits.
The drug was approved based on two studies that showed better outcomes for patients taking twice-daily Eliquis rather than receiving an injection of the typical current treatment. Bleeding side effects were approximately the same between the two groups. All patients studied had undergone orthopedic surgery to replace a knee or hip, a procedure that raises the risk of blood clots.
Eliquis has been touted as a potential blockbuster drug for its ability to prevent blood clots without the bleeding side effects of older drugs like warfarin. However, last year the companies had to halt a 10,000-patient study of the drug in people with a history of heart disease after an unexpected number of bleeding side effects.
Apixaban works by blocking a clotting protein called factor Xa, which is part of the clotting reaction. That is in contrast to other blood thinners, which work by preventing platelets from sticking together.
The drug is not available in the U.S., though Pfizer and Bristol-Myers plan to submit it to the Food and Drug Administration later this year. The companies are seeking approval to prevent stroke in patients with a type of heart defect.