Eli Lilly (NYSE: LLY ) was hoping to have its potential blockbuster, prasugrel, on the market this year. Instead it'll have to settle for knowing that a decision from the Food and Drug Administration is relatively imminent.
Relative to how long it's waited, that is.
Eli Lilly and partner Daiichi Sankyo were expecting to hear from the FDA in June. Then the FDA bumped it to September. And Lilly's been waiting for a decision about whether the agency will approve the blood thinner ever since.
But today the companies found out that the drug will be reviewed by a panel of experts on Feb. 3. As I speculated earlier this month, the drug was likely sent out for review because there's probably an internal debate at the FDA over the risk/benefit balance for prasugrel. The drug clearly works, but the excessive bleeding seen in some patients is reason for concern.
I think the panel will likely give the drug the green light. The harder thing to predict, though, is how restrictive a label the FDA might slap on it, which could hamper sales of the drug. It will be competing directly with Sanofi-Aventis (NYSE: SNY ) and Brisol-Myers Squibb's (NYSE: BMY ) Plavix, so a restrictive label could hurt.
The slow and underfunded FDA has cost Eli Lilly, Johnson & Johnson (NYSE: JNJ ) , and Pfizer (NYSE: PFE ) , among others, some significant revenue this year and next as it has delayed decision after decision. For instance, Plavix is bringing in over $1 billion in U.S. sales per quarter. Eli Lilly would certainly like a shot at that, but instead it's been twiddling its thumbs for several quarters.
Maybe the agency can set a New Year's resolution for 2009: Go back to its goal of acting on 90% of the marketing applications before their PDUFA dates. That would be a nice belated Christmas present for investors.
Make your own Foolish resolutions in 2009:
RSS Headlines
Fool UK