A 20-2 Win For Obesity Drug
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?Qnexa will be a major blockbuster.? |
I am happy to see the advisory panel to the FDA overwhelmingly recommend approval of Vivus drug Qnexa. This was the second try by Vivus with the panel, who rejected it late 2010. I was critical of FDA for delaying the approval because of the pressing need for a drug to help curb our biggest health crisis.
The 20-2 vote means FDA will approve it. There will be caveats and restrictions that Vivus will agree to make sure it is used initially by only the truly obese. There will be warnings for pregnant women, the group of concern because of potential birth defects. In the first year of marketing I am sure Vivus will make sure the drug is limited to endos or obesity specialists. No one wants a phen-phen situation where
the drug is mass used before all the safety risks emerge.
Longer term, I have no doubt that Qnexa will be a major blockbuster of more than $2 billion in sales, and will make its way down from use by the obese to use by the broader overweight population. Vivus needs to be patient and really allow for any unexpected side effects to be seen in widespread use. This might take a year or two. Once the safety profile is tested and no serious side effects are seen, this drug will see quantum growth.
I am sure Vivus will not do DTC for at least a year. This is, longer term, the ideal DTC drug. One can imagine the testimonials of real patients, real obesity specialists who will laud the performance of Qnexa. The drug is quite effective and leads to 10% weight loss on average. That is a lot and most of us would be very happy to lose 10%. That amount of weight reduction will help people reduce high blood pressure, diabetes, and heart disease. If Qnexa is proven safe long-term, imagine the savings to our health care bills in America through wide use.
I know the drug critics will say this drug enables the bad habits of most Americans to continue. I wish we all would walk 30 miles a week (I do) and eat more green vegetables. Sadly, our gluttonous behavior will continue and pill therapy will be needed. I would rather have less weight related diseases than push a diet and exercise message that likely fails. Exercise and healthy eating is the preferred route and the government should try to save our kids through massive education programs. For most over 40, somehow I doubt the bad habits can be changed.
I am thrilled with the panel?s decision. It will encourage all drug makers to focus more research attention on obesity. There is a solution to appetite control in our complex brains and we need as many companies as possible seeking these answers. Good luck Vivus.
Bob Ehrlich, Chairman
DTC Perspectives, Inc
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