The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said it has recommended granting marketing authorization for Lundbeck’s (OMX: LUN) and Biotie’s (OMXH: BTH1V) Selincro (nalmefene) for the reduction of alcohol consumption in adults with alcohol dependence. The aim is to help lower alcohol consumption with high risk drinkers and the recommendation is that the drug should be prescribed in combination with psychosocial support that focuses on treatment adherence and reducing alcohol consumption.
A positive opinion had been rather unanimously expected. The bigger issue was what kind of label would be given. The requirement for psychosocial support wasn't unexpected but it does make sales predictions rather difficult and analysts appear really torn on peak sales guidance. Lundbeck too has referred to the drug as some kind of a wild card with the entire treatment concept being completely novel. Both companies responded with a rather mild positive uptick. Final approval decision is expected in 2-3 months.
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