Obesity Pill Makers in Focus as EMA CHMP Denies Belviq MAA (ARNA) (VVUS) (OREX)
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VIVUS, Inc. (Nasdaq: VVUS) and Orexigen (Nasdaq: OREX) are seeing some notable pressure following disclosure by Arena Pharmaceuticals (Nasdaq: ARNA) that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a Day 180 List of Outstanding Issues.
The CHMP gave Arena Day 180 on its Marketing Authorization Application (MAA) for Belviq, Arena's weight-loss pill which was recently approved by the U.S. FDA.
Though the CHMP cited previous issues for the Day 180, the action hints at further risk-to-benefit analysis for obesity pills. As VIVUS and Orexigen move to introduce their medications into Europe, the pharmas might also come up against the same sort of concerns.
Notably, VIVUS was denied approval of its Marketing App for Qsymia back in October, but has plans to appeal the verdict.
Arena is down 9.8 percent, Orexigen is off 1.3 percent, and VIVUS is up 1.5 percent Tuesday.
The CHMP gave Arena Day 180 on its Marketing Authorization Application (MAA) for Belviq, Arena's weight-loss pill which was recently approved by the U.S. FDA.
Though the CHMP cited previous issues for the Day 180, the action hints at further risk-to-benefit analysis for obesity pills. As VIVUS and Orexigen move to introduce their medications into Europe, the pharmas might also come up against the same sort of concerns.
Notably, VIVUS was denied approval of its Marketing App for Qsymia back in October, but has plans to appeal the verdict.
Arena is down 9.8 percent, Orexigen is off 1.3 percent, and VIVUS is up 1.5 percent Tuesday.
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