The decision was based on the results of three pivotal trials which showed Selincro helped reduce alcohol consumption by 40% within the first month and by around 60% after six months.
Anders Gersel Pedersen, Head of Research & Development and Executive Vice President at Lundbeck, called the drug the “first major innovation in the treatment of alcohol dependence in many years.”
The authorisation applies to all 27 European Union member states. Lundbeck now expects to launch the drug in the next few months.
The tablet will be available to the patient each day when they feel at risk of drinking. Selincro will be provided as part of a novel treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence.
“The approval of Selincro is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment,” said Anders Gersel Pedersen.