“Vivus also took a bold step in proclaiming that it would be ready to market and sell Qysmia by the fourth quarter of 2012, possibly making it the first obesity drug to make it to market in 13 years.”
Vivus’ weight-loss drug, Qysmia has been approved by the U.S. Food and Drug Administration, making it the second such drug to be approved by the regulatory body in less than a month. At the end of the June, the FDA approved Arena’s obesity drug, Belviq. In announcing the approval, Vivus also took a bold step in proclaiming that it would be ready to market and sell Qysmia by the fourth quarter of 2012, possibly making it the first obesity drug to make it to market in 13 years. Vivus dropped the name Qnexa in favor of Qysmia after the FDA complained that too many drugs ended in the same letters.
As the obesity epidemic continues to expand in the United States and throughout the world and in turn raise the risk of such conditions as diabetes, heart attack, and stroke, it has become a public health issue and placed a larger priority to curb its prevalence. The U.S. Centers for Disease Control and Prevention estimates that direct and indirect costs of obesity cause the U.S. economy $147 billion annually in medical expenses and lost productivity.
Though the recent approvals of both Belviq and now Qysmia represent a big step in bringing new obesity drugs to patients for the first time in more than a decade, the explicit restrictions placed on both drugs’ labels suggest a less rosy picture.
Both Arena and Vivus, in securing approval for their drugs, agreed to conduct post-market studies to assess the safety and effectiveness of the weight-loss drugs. Arena has agreed to conduct six post-market outcomes trials to assess Belviq’s major cardiac risks, while Vivus must conduct 10 such studies on Qysmia.
Along with carrying an increased heart rate warning Qysmia also comes with a specific set of dosage guidelines provided by the FDA. For one, women who are of child-bearing age who are taking the drug must only do so if they are on birth control. Secondly, patients who don’t lose 3 percent of their weight by week 12 on a recommended dose of 7.5 milligrams phentermine and 46 milligrams of topiramate (the two active ingredients in Qysmia) are allowed to go up in dosage, but must get off the drug if they don’t see at least a 5 percent drop in body weight after another 12 weeks of therapy.
While critics such as Public Citizen, a Washington D.C. based advocacy group, have pegged the FDA’s approval of Qysmia as “reckless”, citing past diet drugs that were cleared and then taken off the market, investors responded enthusiastically to the news.
Vivus’ shares surged more than 15 percent after the approval to reach as high as $32.49 a share in intraday trading. Arena’s shares slipped 8 percent on the news suggesting that its estimates of an early 2013 market launch for Belviq would be beaten by Vivus’ fourth quarter 2012 estimates for Qysmia.
July 20, 2012
http://www.burrillreport.com/article-vivus%e2%80%99_obesity_drug_gains_fda_approval.html