For the first time in 13 years, two new obesity drugs have been approved by the FDA. Obesity is a rising issue in the United states and according to the Center for Disease Control, 35.7 percent of adults were obese and 17 percent of children were obese in 2010.The two drugs that will be available in the United States are called Belviq made by Arena Pharmaceuticals and Qsymia made by Vivus.
The FDA has set a high bar for approvals of obesity drugs knowing that millions of Americans would be tempted to take weight loss pills. "It appears that the agency's view has officially shifted towards 'not treating obesity is a risk in and of itself, so we're willing to put drugs in the market in order to help people lose weight, even if there's risk associated'," Cowen and Co analyst Simos Simeonidis said in a research note to Reuters.
Vivus Inc, however recently announced that its first diet pill launched in over a decade will be unlikely to pbe recommended by a European regulatory committee.
"An eventual approval in EU seems problematic, given that the issues raised by (the EU committee) seem more related to the lack of comfort with phentermine in Europe, rather than the data itself," Cowen and Co analyst Simos Simeonidis said to Reuters.
Popular weight loss drug fen-phen was taken off the market in the late nineties after harmful side effects were found. Like phen phen Vivus's Qsiva contains appetite suppressant phentremine which is combined with topiramate, which is an anti-seizure drug.
A formal decision on Qsiva from the European Medicines Agency Committie for Medicinal Products for Human use will be expected in October.
"The largest impact on Vivus is that it may remove at least some of the acquisition premium assigned by some investors, since a lack of ex-U.S. revenue makes an acquisition by a large pharma less likely, albeit possible," Cowen's Simeonidis said to Reuters.
Vivus's Qsymia was approved in July in the U.S. with the regulator also approving Arena Pharamceuticals Inc's Belviq in June.
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