Based on our Pharmacor advisory service entitled Obesity, Decision Resources is offering an exclusive analyst call entitled Yet Another Obesity Agent Fails to Impress FDA Panelists – Will a Suboptimal Risk-to-Benefit Ratio Seal the Fate of Arena’s Lorqess? Because this presentation will feature major updates, it is ONLY available to purchasers of this Pharmacor advisory service.

Arena’s Lorqess was the second obesity agent in recent months to receive a negative recommendation from an FDA advisory panel. Like Vivus’s Qnexa, which the FDA advisory committee recently voted against approving, there were safety issues surrounding Lorqess that concerned the committee. The main issues were the incidence of breast cancer in rodent studies and lingering concerns about cardiac valvulopathy due to Lorqess’s similarity to Wyeth’s Redux, an agent which is one half of the ill-fated fen-phen combination.

Although there were questions regarding its safety, the main issue that concerned panelists was Lorqess’s weak efficacy data—many panelists do not believe that the risk/benefit ratio warrants the use of this agent. As a result, the panel voted 9-5 vote against approval of Lorqess.

One day prior to the Lorqess’s negative recommendation, the FDA panel met to decide the fate of Abbott’s Meridia, which had already been withdrawn in Europe earlier this year following release of data from the SCOUT clinical trial. The panel remained divided as to whether Meridia should remain on the market. As a result, the future of the obesity drug market—which has been plagued by safety issues and a dearth of efficacious agents—remains uncertain at this time.

Date & Time
Tuesday, September 28, 2010
10 a.m. U.S. Eastern Time,
4 p.m. Central European Time

This 15-minute analyst call, presented by Decision Resources Analyst Kate Sullivan answers the following questions:

• What impact will the FDA advisory committee’s decision have on Lorqess’s future and on the obesity market forecast as a whole?
• How will this event affect the prospects for Orexigen’s Contrave, the third of the late-stage obesity therapies that will face FDA scrutiny in December?
• How is the FDA likely to react to the advisory panel’s split vote on Meridia?
• What is the outcome of Decision Resources' new market forecast following our analysis of the regulatory prospects for all three emerging obesity therapies? 

Contact us to learn how you can purchase this service and attend this event.

Click here to view the invite.