FDA Advisory Panel Gives Green Light to Qnexa Diet Pill 2

Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of  phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this would have to be completed prior to approval.

Birth defects associated with Qnexa were another source of concern. The panel expressed strong support for a risk evaluation and mitigation strategy (REMS) to accompany any approval. But the panel ultimately was impressed by data showing a 10% weight loss at two years for people taking the drug.

“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” panel member Sanjay Kaul told Bloomberg News.

Kaul told CardioBrief that the 20-2 vote appears more enthusiastic than the actual sentiment of the panel. Panel members remain concerned about the uncertainty regarding cardiovascular risk of the drug, including the possible adverse effects on blood pressure and heart rate. Kaul said the panel was impressed by the company’s proposed REMS, but that there is little evidence demonstrating that even a strong REMS can significantly reduce adverse outcomes like birth defects.

Two other diet drugs, Contrave, the combination of naltrexone and bupropion, from Orexigen, and locaserin, from Arena, have been struggling to gain FDA approval in recent years. No new diet drug has been approved for marketing in the United States since 1999.

Advertisements

2 comments

  1. It is quite curious that over the period of two years the Advisory Committee went from strong opposition to overwhelming support of that drug. However, it is common knowledge that weight loss cannot be achieved without a certain change in your behavior and drugs can only be a part of the answer. That’s why I think that Qnexa will be similar to some controversial diets that promise miraculous effects but the result is often disappointing.

What do you think?

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