Bristol-Meyers (BMY) and Pfizer (PFE) Get FDA Fastrack For Eliquis

A promising new drug from Bristol-Meyers Squicc Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) shown to be better than warfarin at preventing strokes in patients with a dangerously irregular heartbeat, may reach the U.S. market quicker after the FDA says it will get an expedited review.

The new drug, Eliquis, would be the third new U.S. treatment for these patients after Xarelto, from Bayer and Johnson & Johnson (NYSE:JNJ), was approved earlier this month, and Pradaxa from Boehringer Ingelheim was approved last year.

Normally, the U.S. Food and Drug Administration (FDA) takes 10 months or longer to review new drug applications but will give Eliquis a quicker review after clinical trials showed the drug was safer and more effective than the decades-old drug warfarin.

The FDA is expected to give a decision on approval by March 28, Bristol and Pfizer said. That would close the gap in the three-way race, as the new treatments compete in an estimated $10 billion market.

“With two alternatives to warfarin currently approved and one on the near horizon, it seems like a dream come true for patients and physicians who have lived with warfarin for the last 40 years,” said Dr. Micah Eimer, a cardiologist in private practice in suburban Chicago.

Warfarin has been a complicated drug to take for many patients with atrial fibrillation because of dietary requirements, bleeding risk, conflicts with other medicines and the need for regular testing to ensure the right concentrations of warfarin are in the bloodstream. Atrial fibrilaation affects more than 2 million Americans. The condition causes blood to pool in the heart and form clots, raising the risk of stroke.

Bristol-Myers shares rose 1.1% on the news, performing better than a slight increase for the wider stock market. Pfizer gained 1.0%. Bayer gained 0.4% in Frankfurt.

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An avid market watcher, Martin enjoys the tech arena the most with the Nasdaq being his main area of focus. A finance major, Martin is working to the goal of one day ringing the bell at the NYSE.
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