Reuters: Regulatory News: UPDATE 1-Pfizer, Bristol get EU nod for blood clot preventer

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UPDATE 1-Pfizer, Bristol get EU nod for blood clot preventer Nov 20th 2012, 19:57 Tue Nov 20, 2012 2:57pm EST * Drug awaiting U.S. approval decision by March 17 * Eliquis seen as future multibillion-dollar seller * Pfizer, Bristol-Myers shares up slightly By Bill Berkrot Nov 20 (Reuters) - European health regulators on Tuesday approved an eagerly anticipated blood thinner developed by Bristol-Myers Squibb Co and Pfizer Inc for the prevention of strokes and blood clots in patients who have an irregular heartbeat known as atrial fibrillation, the companies said. The drug Eliquis, also known as apixaban, is widely considered one of the most important new products for the two U.S. drugmakers, with multibillion-dollar annual sales potential. The U.S. Food and Drug Administration is expected to make its decision on the drug for use in the world's biggest market by March 17, after delaying a decision in June so that the agency could review additional information from clinical trials of the medicine. The European Commission approval marks the first regulatory approval for Eliquis for stroke prevention in atrial fibrillation patients in any market, the companies said. Eliquis belongs to a new class of medicines designed to replace decades old warfarin for the prevention of dangerous blood clots in heart patients and after certain orthopedic surgeries, such as hip and knee replacements. Atrial fibrillation, which greatly increases the risk of strokes, is considered by far the largest and most important use for the new drugs, that include Xarelto from Bayer and Johnson & Johnson, and Pradaxa from privately-held Boehringer Ingelheim. In clinical trials, Eliquis demonstrated superiority over warfarin in reducing the risk of strokes, major bleeding and death. Warfarin, which has been widely used for more than half a century, is inexpensive and works well, but requires close and regular patient monitoring as well as lifestyle and dietary changes that are not necessary with the newer medicines. "Patients with atrial fibrillation have a five times greater risk of stroke and there remains a critical public health need for improved treatment options to reduce this risk," Lars Wallentin, director of cardiology at Uppsala Clinical Research Centre and University Hospital in Sweden, said in a statement. "The approval of Eliquis represents an important new treatment option for health care professionals, who now have an oral anticoagulant with superior outcomes versus warfarin," he said. Wall Street analysts have said based on clinical efficacy and safety data that they believe Eliquis will become the dominant player in an estimated $10 billion market for the new blood thinners once it receives U.S. approval. Pfizer Chief Executive Ian Read, in a statement, said he believes Eliquis "has the potential to transform the standard of care in stroke prevention in nonvalvular atrial fibrillation". Pfizer shares were up 7 cents at $24.21 and Bristol-Myers shares were up 8 cents at $32.11, in afternoon trading on the New York Stock Exchange. Link this Share this Digg this Email Reprints

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