on a high dose, compared with less than 2 percent on a placebo in a pair of trials after a year of observation. The FDA typically likes to see at least a 5 percentage point advantage for obesity drugs over a placebo, so that beat an important FDA benchmark. The most common side effects were dry mouth, tingling, constipation, altered taste, and insomnia, Vivus said at the time. FDA staff reviewers, in briefing documents posted yesterday, said Qnexa helped people lose weight, but, as noted by Reuters, the FDA also pointed to the drug’s possible effects on heart rate, depression and pregnancy.
It’s the FDA staff’s job to look as hard as they can for the fly in the ointment, and when the briefing document came out, Wall Street generally exhaled. Cory Kasimov, an analyst with JP Morgan who follows Vivus, wrote yesterday that FDA staff were “far more benign” in their questioning of the Vivus application than most investors were expecting. Vivus stock shot up 17 percent yesterday on five times the normal trading volume to close at $12.44, heading into tomorrow’s panel meeting.
Besides tomorrow’s panel, the next most important date to watch for Vivus followers is Oct. 28, the FDA’s deadline to complete its review of its application.
The agency has its hands full reviewing this current crop of obesity drugs. Arena, which was the first to sign up a Big Pharma partner, is gearing up for its appearance before an FDA panel on Sept. 16, followed by its FDA review deadline of Oct. 22. Orexigen’s big days on the calendar are a little further behind—Dec. 7 for the advisory panel, and Jan. 31 for the FDA deadline.
As Leerink Swann’s Yoo says, each of these drugs has advantages that it will use to try to persuade physicians that its drug is the best-in-class. There is going to be fierce jockeying in the marketing world over how to position these products in the minds of physicians and consumers. As I pointed out in this feature story last September, the companies were already rehearsing their TV commercial lines then. Vivus was positioning its product as the one likely to help people lose the most weight, Orexigen is hoping to say it helps treat related illnesses that stem from obesity (like diabetes), while Arena wants to pitch itself as the safest option for the masses.
I am not planning to cover the blow-by-blow of tomorrow’s FDA advisory meeting, what with a bunch of other deadlines, and the fact that all the major newspapers and wire services will be sure to keep you informed about what the FDA panel has to say about the Vivus drug. I will plan to write a wrap-up story shortly after the wires move their headlines tomorrow afternoon. But this will be a major ongoing story we at Xconomy plan to watch in the months ahead, so stay tuned.
