EU drug agency to finalise Acomplia review in July
LONDON, June 29 (Reuters) - European regulators are still reviewing the latest safety data on Sanofi-Aventis SA's (SASY.PA: Quote, Profile, Research) obesity drug Acomplia and will only come to a final decision next month, an official said on Friday.
"The review is expected to be finalised at the July CHMP (Committee for Medicinal Products for Human Use) meeting," a spokeswoman for the European Medicines Agency said.
The EU watchdog had initially said it was likely to give a view this month.
The close review of Acomplia's safety profile comes two weeks after a U.S. advisory panel said the medicine should not be approved in the world's biggest drugs market because it may increase suicidal thinking and depression.
Acomplia, also known by the brand name Zimulti and generically as rimonabant, has been on sale since 2006 in Europe, where it is not recommended for patients with major depression due to its possible psychiatric side effects.
"The review is expected to be finalised at the July CHMP (Committee for Medicinal Products for Human Use) meeting," a spokeswoman for the European Medicines Agency said.
The EU watchdog had initially said it was likely to give a view this month.
The close review of Acomplia's safety profile comes two weeks after a U.S. advisory panel said the medicine should not be approved in the world's biggest drugs market because it may increase suicidal thinking and depression.
Acomplia, also known by the brand name Zimulti and generically as rimonabant, has been on sale since 2006 in Europe, where it is not recommended for patients with major depression due to its possible psychiatric side effects.
