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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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.