FDA Approves New Blood Thinner Medication

After an 18 month long review, the U.S. Food and Drug Administration has approved the sale of a new blood thinning medication, Effient, developed by Eli Lilly and Danchii Sankyo. Effient, whose chemical name is prasugrel, has been approved for much more limited use than its closest chemical rival, Plavix.

Eli Lilly conducted a study of more than 13,000 patients showed that Effient prevented more heart attacks than the second best-selling drug, Plavix. But Effient also caused more episodes of internal bleeding, which has resulted in the FDA requiring the drug's packaging to carry the sternest warning available, namely the black box on the label.

The black box is designed to cause health-care providers to pay extra attention to the possible side effects of a drug, which in Effient's case is the chance of internal bleeding, which at times could be fatal.

Plavix, a drug that helps to prevent blood platelets from sticking together and forming clots, is a product of Bristol-Myers Squibb and Sanofi-Aventis companies. This medication has been approved for use among a wide variety of patients to prevent conditions such as heart attack and stroke. Effient has been approved for use only for those people undergoing angioplasty, a procedure in which a balloon-like device is used to clear plague from the coronary arteries.

Effient is not to be used in patients with prior bleeding problems, those about to undergo surgery, or those who have experienced a stroke.

Analysts on Wall Street are predicting Effient's annual sales may be near the $1 billion mark compared to Plavix which hit sales of $4.9 billion in 2008 (Associated Press).

Approval of Effient for the Eli Lilly company was important, not only as the culmination of 10 years of research by the company and its partner in this endeavor, Danchii Sankyo, but also because the patents on the company's four top selling drugs are set to expire by 2013. When patents expire, other manufacturers are free to develop generic equivalents of each drug, lowering the profit for the original parent company.

Sources: Associated Press
Reuters