Danish drugmaker Lundbeck won a European green light on Friday for its new alcohol dependency drug Selincro, boosting its product portfolio at a time when its biggest product faces a big drop in sales.
Lundbeck needs new drugs to replace lost sales from antidepressant Cipralex, sold as Lexapro in the United States and Japan, which is now coming off patent.
The European Medicines Agency (EMA) said on Friday it recommended approval of Selincro in conjunction with psychosocial support for the reduction of alcohol consumption in adults with alcohol dependence.
Recommendations from the EMA are normally endorsed by the European Commission within two or three months, implying the drug could be launched in Europe early next year.
Selincro, which blocks the action of opioid receptors in the brain, was licensed to Lundbeck from Finland’s Biotie Therapies.
Shares in Biotie jumped more than 11 percent on the news, while Lundbeck rose around 1 percent.
Selincro breaks new ground as a treatment for reducing alcohol consumption and Lundbeck CEO Ulf Wiinberg told Reuters last week it was “a bit of a joker in our portfolio” because of uncertainty as to how it will be used.
Analysts currently pencil in only modest sales for the product.
(Reporting by Ben Hirschler; editing by Chris Wickham)