The make-or-break FDA advisory panel meeting on diet drug rimonabant (Acomplia / Zimulti) will be the subject of team coverage on June 13th by staff of the Zimulti Acomplia Report, leading independent source of news about rimonabant.

The day-long meeting, which will air concerns raised about "rimonabant and increased rates of psychiatric adverse events, including depression and suicidality, and neurological adverse events, including seizures," will see members of the committee vote on a variety of recommendations to the FDA.

The recommendations of members of the FDA's Endocrinologic and Metabologic Advisory Committee are expected to weigh heavily on the decision of the FDA, expected in late July, whether to approve marketing of Zimulti in the United States.

The draft questions that the FDA staff has asked the advisory panel to consider are these:

1a. Do you believe that rimonabant causally increases the incidence of:

• Suicidality?
• Psychiatric adverse events other than suicidality?
• Neurological adverse events other than seizures?
• Seizures?

1b. If yes to the above, do you believe that the increases are, or will be, clinically important?

2a. Do you believe that the currently available data sufficiently characterize rimonabant’s safety profile?

2b. If no, please discuss what additional data should be obtained.

3a. Based on the currently available data, do you believe rimonabant has a favorable risk-benefit profile and should be approved for the indication of weight management in individuals with a body mass index of > 30 kg/m2 and > 27 kg/m2 when accompanied by at least one comorbid condition?

3b. If no, please explain why and discuss what additional information the
sponsor could obtain that might improve rimonabant’s risk-benefit profile.

3c. If yes, are there specific labeling recommendations that you have?

We certainly agree with the FDA staff that we are "looking forward to an interesting meeting on June 13th," and you will be able to read all about it in fullest detail here on the Zimulti Acomplia Report.