As generic competition slashes sales of top-selling drugs, the development of new drugs has become essential for Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY). The approval of their new anti-clotting drug, Eliquis, by European Union regulators could hand the pharmaceutical manufacturers a a billion-dollar blockbuster.
Advisers to the European Union have already recommended the approval of the new anti-clotting drug for use by adults with the most common type cardiac arrhythmia, atrial fibrillation, that increases the risk of strokes or blood clots. If the drug is approved, sales would be allowed in all 27 member states of the EU, as well as Iceland and Norway.
Eliquis has already been approved by the European Union in 2011 for preventing blood clots following hip or knee replacements surgeries, but the U.S. Food and Drug Administration has rejected the drug twice, its last refusal coming in June. The FDA said it needed more information on “data management” by the companies and verification from the international study Aristotle.
The drug, known chemically as apixaban, is one of three new drugs being developed currently that may be able to prevent blood clots, and the strokes and heart attacks they trigger. Boehringer Ingelheim’s Pradaxa was approved for sale in the U.S. in 2010, and a joint effort between Johnson & Johnson (NYSE:JNJ) and Bayer Healthcare was approved in 2011.
Both patients and doctors alike have long waited for a better alternative to the inexpensive generic drugs currently on the market, some of which carry risks of internal bleeding.
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