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Sanofi-Aventis' Zimulti: Knowing When to Say When

This article was originally published in RPM Report

Executive Summary

Rimonabant had all the early signs of a mega-blockbuster. But behind that shiny veneer was a drug with a serious risk profile-one that mimicked the suicidality rates of the SSRI class. That made rimonabant an enormous red flag for FDA reviewers. Why didn't Sanofi-Aventis see it coming?

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The Qnexa Vote: Beyond the Bean Counting

FDA's Endocrinologic & Metabolic Drugs voted 10-6 against approval of Vivus' weight loss drug Qnexa (phentermine/topiramate) at this time. But committee members were almost unanimous in agreeing that it was a very close call, and their comments captured the nuance of the many issues FDA must resolve in the context of reviewing weight loss drugs in general and this application in particular. Below is our transcript of the discussion by each panelist about the reasons for their vote.

Weighing the Regulatory Climate: Qnexa and the New Approval Model

If you are looking for evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA's handling of Vivus' weight loss drug Qnexa: FDA's review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.

Weighing the Regulatory Climate: Qnexa and the New Approval Model

If you are looking for evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA's handling of Vivus' weight loss drug Qnexa: FDA's review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.

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