Hope springs eternal with the FDA and VIVUS

Vivus announced today that they have resubmitted Qnexa to the FDA, updating their suggested label that the drug should not be used by women of child-bearing age.

Sounds like a great plan, correct?  The FDA was concerned about the risks of birth defects when it previously reviewed the phentramine/topiramate last October.  According to the news today, Vivus also submitted a risk mitigation and evaluation plan to the agency.

I gave up betting some time ago, when my wife noticed that I had a horrible tendency to lose when gambling.  That being said, would anyone like to bet on the approval of Qnexa next year?

Unless Vivus provided a very well characterized risk mitigation strategy, e.g.  a closed/limited distribution approach, a physician registry, or some other novel plan that would give the FDA confidence that Vivus could ensure that women of child bearing age would not be prescribed Qnexa or access it, I do not see a regulator willing to take that risk.

Is obesity a terrific problem? Yes.

Do we need therapies to address in combination with lifestyle interventions? Yes.

Is Qnexa the vehicle to be the first obesity drug approved in over ten years?  That is the question for the agency.

Advertisements
Post a comment or leave a trackback: Trackback URL.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: