Qnexa, the weight loss drug developed by Vivus, was backed 20-2 by the FDA Endocrine and Metabolic Disease Advisory Committee. Almost all patients on Qnexa lost about 10 percent of their baseline weight over a year compared to placebo. Qnexa was rejected last year because of Avandia stoked worries about cardiovascular risks, particularly high blood pressure. This time around, Vivus did an additional study and focused on cardiovascular endpoints and markers among various subgroups. The study found among many groups that blood pressure and inflammatory markers declined along with a loss of weight. " Effects of treatment on biomarkers of cardiovascular disease risk, such as hs-CRP, adiponectin, and fibrinogen, were measured in study OB-303. Treatment with QNEXA Top and Mid dose resulted in statistically significant mean changes in hs-CRP, adiponectin, and fibrinogen. The magnitude of reduction in hs-CRP appears to be comparable to those observed in the JUPITER trial with rosuvastatin." And Vivus will closely evaluate how people respond to Qnexa in the real world.
The emphasis on sub-group analysis to establish which patients would benefit most from Qnexa -- with an emphasis on collecting data from everyday patients -- reflects both a shift in the Vivus strategy and a change in FDA's outlook. I think going forward a Steve Nissen will not be able to trash drugs of companies that he doesn't work for to the advantage of products from firms that he does with a sloppy meta-analysis. (As as aside, Nissen's use of a meta-analysis to attack Eric Topol's research on the value of using gene tests to select drugs for stenting procedures was recently laughed off and ridiculed.) And companies that want to move a new product to market would do well to seek approval based on those sub-groups where the benefits exceed the risk. And to be able to monitor disease progression and treatment response after market with simple blood tests would advance approval even more. The more risk can be defined and measured at the subgroup or individual level, the less chance anti-innovation forces will have to block new devices and drugs that have clinical utility.
That's what The Critical Path was supposed to do. It sounds like the Qnexa decision was made consistent with that mission.
http://www.fda.gov/.../Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM292317.pdf
The emphasis on sub-group analysis to establish which patients would benefit most from Qnexa -- with an emphasis on collecting data from everyday patients -- reflects both a shift in the Vivus strategy and a change in FDA's outlook. I think going forward a Steve Nissen will not be able to trash drugs of companies that he doesn't work for to the advantage of products from firms that he does with a sloppy meta-analysis. (As as aside, Nissen's use of a meta-analysis to attack Eric Topol's research on the value of using gene tests to select drugs for stenting procedures was recently laughed off and ridiculed.) And companies that want to move a new product to market would do well to seek approval based on those sub-groups where the benefits exceed the risk. And to be able to monitor disease progression and treatment response after market with simple blood tests would advance approval even more. The more risk can be defined and measured at the subgroup or individual level, the less chance anti-innovation forces will have to block new devices and drugs that have clinical utility.
That's what The Critical Path was supposed to do. It sounds like the Qnexa decision was made consistent with that mission.
http://www.fda.gov/.../Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM292317.pdf
