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June 15, 2007

This one may hurt.

Analysis of: FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors | www.medicalnewstoday.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Howard Weintraub, MD
Clinical Director, NYU Medical Center
Implications: It is clear that the advisory panel is more concerned with safety in a limited population that the broader impact of obesity and its metabolic problems and acceleration of diabetes and atherosclerosis. This demonstrates the likelihood that the FDA will likely be posturing to reflect the rosiglitazone mess (with Baychol and Vioxx undertones). This is going to create a real challenge for Sanofi and make them pray for succes with the "son of amiodarone".

Analysis: It is disppointing to see this decision. While not perfect, the data from the RIO trials and Rhapsody showed real promise in obese patients with elevated lipids, DM or metabolic syndrome. The impact of even 10-12 pounds weight loss can be great in these patients and is certainly safer than the other pills that are out there. It may cause a surge in off label use of Byetta, as many of these patients and thier doctors are very frustrated.
It will certainly hurt Sanofi. However, I was surprised to learn today that thay plan to go ahead with their plans to train their staff on this drug.

Other Analyses of the Same Source Article:
Is Suicide Painless? Why Zimulti/Rimonabant Has a Second Chance.
June 15, 2007, Author: GLG Expert Contributor
This one may hurt.
June 15, 2007, Author: Howard Weintraub, MD, Clinical Director, NYU Medical Center
Safety Concerns Trump Public Health Benefit in the Eyes of the FDA Cardiorenal Panel
June 14, 2007, Author: GLG Expert Contributor

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