US-based biopharmaceutical firm Arena Pharmaceuticals is seeking European marketing approval for its weight loss and weight control medication lorcaserin.
The company has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for the drug, with Arena expecting the agency to accept it later this month.
Arena president and CEO Jack Lief said that the company looked forward to the potential approval of the drug for EU member countries, citing the need for weight control treatments in the region.
"With rates of obesity tripling in many European countries over the last thirty years, there is a substantial unmet need for new treatments to manage weight," Lief explained.
The drug was assigned a new Prescription Drug User Fee Act target date of June 27, 2012, by the US Food and Drug Administration following Arena’s resubmitted New Drug Application, which was filed in December 2011. In a deal with Arena Pharmaceuticals, Japanese drug firm Eisai retains the exclusive rights to market and distribute the drug within the US should it receive FDA approval.
Arena has retained the rights to market the drug outside of the US, and holds patents to cover lorcaserin in the US, major European nations and other jurisdictions that can continue to 2023.