Arena Withdraws Application for Weight-Loss Drug Approval in Europe
May 3rd 2013 8:30AM
Drug maker Arena Pharmaceuticals Inc. (NASDAQ: ARNA) has withdrawn its application for European regulatory approval of its weight-loss drug Belviq. The drug was approved for use in the United States last June.
Arena made its announcement last night when it reported first-quarter earnings. The company said it is "currently evaluating the best approach for submitting at a later date."
Belviq is one of three new weight-loss drugs from different makers, and was the first new medicine of its kind to receive U.S. Food and Drug Administration (FDA) approval in 13 years. Qsymia, from Vivus Inc. (NASDAQ: VVUS) and Contrave from Orexigen Therapeutics Inc. (NASDAQ: OREX) are the others. Qsymia has also received FDA approval while Orexigen is expected to reapply for Contrave approval later this year or early next.
Arena is likely to have withdrawn its application in order to avoid being rejected by the European regulators. None of the three competing weight-loss drugs has been approved for use in Europe.
Shares of Arena are getting hammered in premarket trading this morning, down about 14.4% to $7.19, in a 52-week range of $2.32 to $13.50.
Shares of Vivus are up 2.7%, at $13.30 in a 52-week range of $9.86 to $31.21.
Filed under: 24/7 Wall St. Wire, Drug companies, Pharmaceuticals, Regulation Tagged: ARNA, OREX, VVUS