EMEA says Acomplia review to be completed for July 16-19 meeting

EMEA says Acomplia review to be completed for July 16-19 meeting

	Published : Fri, 29 Jun 2007 16:40 By : Agencies Print this Story

adds quote to clarify timetable, comment from spokesperson

PARIS (Thomson Financial) - The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) said it is currently reviewing data regarding psychiatric effects of Sanofi-Aventis' Acomplia drug and expects to announce its conclusions at the end of its July 16-19 meeting.

'The CHMP, as part of the continuous monitoring of the safety of Acomplia/Zimulti (rimonabant), is currently reviewing the available data on psychiatric events (in particular suicidal ideation and depression-related events),' the committee stated in its monthly report for June.

'The review is expected to be finalised at the July CHMP meeting and its outcome will be communicated then,' the report said.

An EMEA spokesperson added that the announcement will be made at the end of the meeting, meaning it will 'most likely' be made either late on Thursday July 19 or on Friday July 20.

Earlier this month, the EMEA said the committee would review Acomplia's licence in the light of the refusal of the US Food and Drug Adminstration's panel of experts to recommend marketing approval, due to concern that suicidal thoughts appeared to be a side effect of the treatment.

In a briefing submitted to the FDA, Sanofi-Aventis had said tests showed rimonabant, the generic name for Acomplia, brings a higher risk of suicidal thoughts than placebo and that it did not recommend the treatment for patients suffering from major depression.

Analysts believe Acomplia now has no chance of a US launch for at least 2-3 years, after further extensive testing.

Rimonabant is currently approved worldwide in 37 countries and is marketed in 18, having won EMEA authorisation for use in the EU to treat obesity on June 20 2006.

Sanofi had planned to market rimonabant in the US under the brand Zimulti.

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