Arena Files for European Drug Review (ARNA, VVUS, OREX)
Drug maker Arena Pharmaceuticals Inc. (NASDAQ: ARNA) announced that its application to sell its lorcaserin weight-loss drug in Europe has been accepted by the Europe Medicines Agency. This is the first step toward a full review of the drug’s acceptability for the European market.
The company also said that it had scheduled a meeting with the US Food and Drug Administration for May 10th to discuss resubmission of the company’s new drug application in the US. Lorcaserin is one of three weight-loss drugs currently in the mix for FDA approval. Qnexa from Vivus Inc. (NASDAQ: VVUS) and Contrave from Orexigen Therapeutics Inc. (NASDAQ: OREX) are the others.
Arena’s shares are up nearly 17% this morning, at $2.81 after posting a new 52-week high of $2.88 earlier. The 52-week low is $1.21.