Will the FDA approve QNEXA or opt for a one-year study and REMS ?

Today marks the day when the FDA is scheduled to make a decision about a second new weight loss drug called QNEXA which is actually a combination of two older drugs. There was concern expressed by the expert panel about benefits versus risks. Previously, the FDA has asked for more data as was the case for lorcaserin-a different weight loss medicine which does not appear to have the same risks as QNEXA.

What will happen? Now that the physician community has a new medicine, the FDA could opt to require additional study which would further define the risks and the population who might be at risk. Given the 6 studies required of the maker of lorcaserin, there most probably will be a REMS AND a requirement for more study. The FDA could also reject the medicine at present and require studies to be conducted on the two FDA approved components. Time will tell and today appears to be the day.

Visit www.fda.gov later today to see the decision.

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