Will Lilly's Effient Make It Through FDA Review?

I thought I was going to be able to skip town for the Rose Bowl without needing to bang out another blog before my plane takes off. I was wrong.

Yesterday morning Eli Lilly (LLY) announced what many analysts had been speculating for months was probably going to happen. The company's all-important bloodthinner Effient will be reviewed by an FDA Advisory Committee in early February.

These outside panels of experts are called on to examine drugs — especially if there are questions about safety — and are asked to make recommendations to the FDA about what to do. The agency usually, but not always, takes the advice.

In this case, there are concerns that Effient may do such a good job thinning the blood of certain patients that they bleed too much.

In the press release, J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for Effient, is quoted as saying, "We have full confidence in the data submitted to the FDA and the overall benefit-risk profile of prasugrel, and we look forward to this next step in potentially bringing an important new alternative to the oral antiplatelet market." (Prasugrel is the generic, scientific name for Effient. )

The FDA has already twice delayed making a decision on whether to approve Effient, which it had put on a fast track for action. Lilly has repeatedly said the filing was ginormous -- that if you printed it out, the paper would stack nearly as high as the Empire State building.

Nevertheless, for months now Lilly has been promoting Effient at scientific conferences and in medical publications, saying, "Coming Soon."

Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY) are having the last laugh. They own the bloodthinner Plavix, which will get to continue to be the unchallenged 800-pound gorilla in that space for at least a little while longer.