The Food and Drug Administration is expected to approve Eli Lilly and Co.’s and Daiichi Sankyo Co Ltd’s anti-clotting drug prasugrel although concerns over the risk of bleeding and other adverse effects remain.

 

The companies’ clinical trial “demonstrated rasugrel's superiority, not to a placebo, but to an active drug ..., prasugrel's efficacy seems beyond question,” according to FDA’s reviewers, who recommended the approval.

 

According to the preliminary analysis, the benefits of the medicine outweigh the potential risks of excess bleeding and cancer.

Outside advisers are expected to consider the findings at a meeting planned for next week when they will decide whether to approve the drug for sale.

Last year, the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) scheduled a public hearing to evaluate the drug in the first quarter of 2009. Developed by Daiichi Sankyo, prasugrel is currently under clinical development in conjunction with Eli Lilly and Company for acute coronary syndrome (ACS) planned for percutaneous coronary intervention (PCI).

 

Recent reports by Bloomberg say that Eli Lilly & Co., a major drug manufacturer agreed to pay $2.6 billion on January 15, 2009 to settle state and federal government allegations of illegal marketing and sales practices.

The company has previously agreed to pay approximately $800 million for unapproved marketing and promotional claims regarding its antipsychotic drug Zyprexa. The company pleaded guilty to one misdemeanor violation of the Food and Drug and Cosmetic Act for the off-label promotion of Zyprexa between September 1999 and March 2001.

If approved, the dug will compete with Plavix, marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.