Written by Stuart Stevens | Monday, 05 June 2006 | There are 0 comments
The makers of the weight loss drug Acomplia say that they are very sure that the drug will get full approval from the EMEA for sale in the European Union in the very near future. The Committee for Medicinal Products with Human Use that is responsible for looking into the safety and health aspects for the EMEA of any newly submitted medicines said at the end of April that Acomplia should be approved for people suffering from obesity and for people with Type 2 diabetes who were overweight. In the vast majority of cases the EMEA takes the recommedations of the CHMP and the whole process is normally rubber stamped within 8 weeks.
Sanofi Aventis is not waiting for the approval before getting organised for the launch of the drug and they are keen to get Acomplia ready for sale in the UK and Germany by the middle of this summer. Plans are afoot for the launch of the Acomplia drug in Ireland, Norway, Finland and Sweden towards the end of September.
The drug has also been through the testing mechanisms of the United States drug authorities namely the Food & Drug Administration and the process is likley not to reach completion for full approval until at least 2007.
Acomplia was originally touted as a weight loss and a smoking cessation drug but the CHMP ruled that they would only consider it for weight loss. In independent tests it has been shown to be good as an appetite suppresant and for lowering levels of bad cholesterol in the blood.
