Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) had approved the drug ELIQUIS, as a treatment for Deep Vein Thrombosis and Pulmonary Embolisms. Each year an expected 900,000 Americans are affected by these ailments, and these events can be fatal.

Deep Vein Thrombosis is a blood clot in a vein that partially or totally blocks the flow of blood, usually from the legs. A Pulmonary Embolism is a blood clot blocking one or more vessels in the lungs.

The FDA is approving ELIQUIS based on the global AMPLIFY study. The study was a double-blind trial of patients symptomatic of Deep Vein Thrombosis or Pulmonary Embolisms. The total number of patients in the study was 5,244. A 10 mg dose of ELIQUIS was taken twice daily for one week followed by a dose of 5 mg twice daily for 6 months.

The press release went on to show that ELIQUIS demonstrated superiority in the primary safety endpoint of major bleeding versus standard of care.  For the secondary safety endpoint in the AMPLIFY study, the event rates for clinically relevant nonmajor bleeding were fewer in ELIQUIS-treated patients compared to standard of care-treated patients.

Warnings for the drug include increased risk of thrombotic events for patients who prematurely discontinue taking the drug. There is also an increased risk of epidural or spinal hematomas, for patients undergoing spinal epidural anesthesia or spinal puncture.

This approval is not likely a market-mover for the stocks because the companies are so large. Still, this is a serious condition where more treatments and better treatments are needed. Pfizer shares were down $0.05 at $28.84 and Bristol-Myers Squibb shares were down $0.15 at $49.89 in Thursday afternoon trading.

 

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