FDA approves use of Eliquis to treat leg, lung clots

by Reuters
Thursday, 21 August 2014 18:44 GMT

(Adds details on Eliquis, rival blood clot drugs)

Aug 21 (Reuters) - Bristol-Myers Squibb Co and Pfizer Inc on Thursday said U.S. regulators have approved an expanded use for their Eliquis blood clot preventer, to treat blood clots in the legs and lungs.

The drugmakers said the U.S. Food and Drug Administration also approved use of the pill to reduce risk of recurrent blood clots in the deep veins of the leg, called deep vein thrombosis, and in the lung, called pulmonary embolism, following initial therapy.

Leg clots, if untreated, can travel to the heart, lungs and brain, and cause heart attacks and stroke. Lung clots, which can choke off blood flow, are linked to high mortality rates and require immediate treatment.

Eliquis, which works by blocking a protein called Factor Xa that is involved in the clotting process, is already approved to prevent strokes in patients who have an irregular heartbeat called atrial fibrillation. It is meant to be an alternative to warfarin, an older oral drug that can cause serious bleeding episodes and comes with strict dietary restrictions and the need for frequent blood checks.

In large clinical trials involving patients with leg and lung clots, Eliquis was shown to cause far fewer cases of major bleeding than standard treatment with blood clot preventer enoxaparin for five days, overlapped by treatment with warfarin. Eliquis was shown to be similarly effective as standard care.

Bristol-Myers and Pfizer are hoping the new approved use for Eliquis will significantly boost demand for Eliquis, whose sales have been very disappointing since it was introduced in late 2012. It garnered $171 million in sales in the second quarter.

That pales with blockbuster sales of a similar drug from Johnson & Johnson called Xarelto, and a different but new type of blood clot preventer called Pradaxa, sold by privately held German drugmaker Boehringer Ingelheim.

(Reporting by Ransdell Pierson; Editing by James Dalgleish and Steve Orlofsky)

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