Sanofi says rimonobant unsuitable for patients with makor depression

Sanofi says rimonobant unsuitable for patients with makor depression

	Published : Mon, 11 Jun 2007 18:55 By : Agencies Print this Story

PARIS (Thomson Financial) - Sanofi-Aventis has told the US Food and Drug Administration its rimonobant anti-obesity drug, also known under the Acomplia brand, brings a higher risk of suicidal thoughts than placebo and does not recommend the treatment for patients suffering from major depression.

The potential blockbuster received a previous setback in April when the FDA extended its review of the drug by three months to July 27 and its Endocrinologic and Metabolic Drugs Advisory Committee is due to meet Wednesday to review Rimonobant, provisionally branded Zimulti in the US.

The drug, which is also designed for treating diabetes, has already been approved for use in Europe, where it is called Acomplia.

In its briefing document for the advisory committee, posted by the FDA on its website, Sanofi said its clinical trials showed that compared to patients taking placebo, 'depressive events were more frequent under rimonabant.'

'A greater incidence of dizziness, anxiety, depressed mood, and depressive disorders was observed in the 20-mg rimonabant group,' for obese patients, the report said.

It said depressive disorders including depression, major depression, and dysthymic disorders were reported more frequently in the rimonabant 20-mg dose group, affecting 3.9 pct, when compared with the placebo group, where this affected 1.7 pct of patients.

The report said 'Sanofi-Aventis is proposing that rimonabant should not be initiated in patients with uncontrolled psychiatric illness such as a major depression.'

'There is limited data in patients taking antidepressant medication in combination with rimonabant; therefore, the use of rimonabant is not recommended in these patients.'

Rimonabant is already on the market in England, Germany, Denmark, Sweden, Finland, Norway, Ireland, Argentina, Austria and France, where it has been approved for reimbursement for social security programmes.

In a note published today, Societe Generale warned that while rimonabant's efficacity is not likely to be an issue 'the FDA might question the benefit/risk ratio -- i.e. is rimonabant sufficiently effective to make its central nervous system side effect profile acceptable?'

The FDA generally follows the advice of the advisory committee but is not obliged to.

The study found that 'depressive disorders, including suicidality-related reactions, were reported in 133 medically confirmed cases', a ratio of 12.2 per 10,000 treated patients.

Of these 133 incidences 26 pct were considered serious and it was found that adverse reactions started during the first month in 99 cases.

54 patients had a prior psychiatric history and/or suffered from psychiatric diseases.

tfn.paris@thomson.com

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