Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Debunking Acomplia

This article was originally published in RPM Report

Executive Summary

Sanofi's Acomplia fit all the criteria for an advisory committee review. But despite some safety concerns, FDA had good reasons not to hold one.

You may also be interested in...



Seeing is Believing: Wall Street's Slow Reaction to Rimonabant

An FDA advisory committee's recommendation against the approval of Sanofi-Aventis' rimonabant caught many investors off guard. It's hard to believe drug safety issues can still surprise Wall Street, but there are some reasons why analysts lacked clarity on rimonabant.

Sanofi-Aventis' Zimulti: Knowing When to Say When

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?

Sanofi's Rimonabant: The Next Drug Safety Victim?

Sanofi-Aventis' investigational weight loss drug rimonabant will be the subject of a high-profile advisory committee review smack in the midst of a sensitive political environment for FDA. But even if Sanofi manages to eke out an approval, it will face yet another marketing challenge: the loss of the well-recognized brand name Acomplia.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT142464

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel