Vivus has announced their decision to ask the European regulators to approve Qnexa. Having been refused approval by the FDA in the United States due to their taking issue with possible risk regarding cardiovascular side effects and birth defects, the pharmaceutical company has stated that it has now addressed the concerns raised by the FDA and independent analysts expect this medication to be approved upon review. The European Medicines Agency will review Vivus’ application shortly.
Since the panel recommendation to approve Orexigen’s Contrave, the outlook for the future approval of weight loss drugs is a bit brighter. We would expect Lorcaserin to be approved as well, even although it was rejected earlier this year.