The final shoe has dropped! In spite of a positive recommendation from the Advisory Committee in December, the FDA has rejected the application for the third diet drug seeking approval in 2010.
The reaction to this rejection came as a surprise to many in the financial community as evidenced by the run up in the stock price of Orexigen prior to the announcement that it was not favorably considered (NFC). As I commented after the Advisory Committee, the FDA will always have the final say. And, it said the benefit risk just wasn’t there.
We’ve had 3 diet drugs fail this year, all because the benefit risk didn’t measure up. I was thinking that this might be a good time for the FDA to revise the Guidelines for diet drugs – require that the weight loss be more than the “cup cake” effect that I’ve talked about before. But then I really started thinking about it. Is 5% weight loss over the course of a year compared to placebo a good target? Yeah, it probably is given that the folks on placebo are probably going to lose some weight. So what’s the problem?
I think the problem is that the developers of these diet drugs are focusing too much on meeting the minimum weight loss target of the guidelines and not enough on the overal benefit risk of the equation. So, what’s the solution? How about some new rules that they can work towards without the FDA stepping in:
1. Set a target weight loss for any new product of greater than 10% for a year. This improves
benefit side of the benefit risk equation for the FDA. Hey, it might help with marketing the
2. Spend some more time in Phase I and Phase 2 doing some pharmacology studies,
especially cardiovascular studies that are designed to provide answers on the tough
issues that have plagued these drugs for decades. Yes, it may knock some of the
candidates out early but think of the money you’ll save on Phase 3 studies that shouldn’t
have been done.
Bottom line – you’ve heard it here before and you’ll hear it here again, it’s all about benefit risk and writing a package insert that can be approved.