The FDA disappointed AstraZeneca and its investors by not approving its heart drug Brilinta, a blood-thinner that the company -- facing a severe patent cliff -- has high hopes for. If approved, it could be a multibillion-dollar blockbuster. But the FDA wants to see more analyses of results from a major study.
More than a year after AstraZeneca filed for approval, the FDA will make its decision on Thursday. A large study showed the blood thinner worked better than Plavix for treating acute coronary syndrome -- but approval isn't a sure thing, due in part to some oddities in the study's results.
It's a busy day at the FDA today as panels meet to discuss two new drugs -- one to help weight loss and the other to combat drug addiction -- and decide whether to approve AstraZeneca's new blood thinner medication.
Several recent studies of drugs used to treat and prevent strokes appear to favor AstraZeneca's (AZN) Brilinta and Eli-Lilly's (LLY) Effient over Plavix. Plavix, co-marketed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY), is the second best-selling drug in the world.
AstraZeneca's core earnings per share rose 9% in the second quarter, helped by a strong performance in emerging markets. While the British pharmaceutical warned the rest of the year will be "challenging," it also raised its 2010 earnings forecast for the third time this year.
