After a delay of three months, the U.S. Food and Drug Administration on Tuesday has finally approved biopharmaceutical company Vivus Inc.'s (VVUS: Quote) Qsymia as an addition to diet and exercise for chronic weight management.
Qsymia, formerly known as Qnexa, has been approved for use in adults who are obese or overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
As the market awaited the regulatory decision, the company's stock was hammered in regular trading as well as extended trading sessions, shaving off a total of $4.05 or about 14 percent.
The FDA had in April deferred its decision on the Qsymia New Drug Application that was resubmitted in October 2011, and set an action date of July 17.
The approval comes a fortnight after the FDA finally approved Arena Pharmaceuticals, Inc's (ARNA: Quote) Belviq or Lorcaserin as the first new drug therapy in nearly thirteen years to treat obesity that is assuming alarming proportions.
Qsymia becomes the second obesity drug to be approved by the FDA in thirteen years, and the first ever once daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related co-morbidity.
Apart from now Qsymia and Belviq, Roche's Xenical, a prescription anti-obesity drug and GlaxoSmithKline plc's (GSK) Alli, an over-the-counter weight-loss product, are the only other two FDA-approved drugs for obesity in the market.
"Qsymia is the first FDA-approved once daily combination treatment for patients struggling with obesity. The degree and severity of obesity and the lack of effective pharmacological interventions that we face as a society were two primary reasons for the development of Qsymia," Vivus President Peter Tam said in a statement.
Qsymia is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine, a generic weight loss drug, and topiramate, used to treat epilepsy and migraines.
The safety and efficacy of Qsymia were evaluated in two randomized, double-blind, placebo-controlled, phase 3 studies that randomized more than 3,700 patients who were obese or obese and overweight with two or more weight-related co-morbidities.
The FDA in a statement noted that patients taking Qsymia for a year experienced an average weight loss of 6.7% in one study and 8.9 percent in another study compared to placebo.
Vivus is now committed to carry out a post-marketing study to alleviate fears that long term treatment effect of the drug causes heart attacks or strokes.
An FDA advisory panel had in February nearly unanimously voted 20 to 2 to recommend marketing approval of Qsymia. Since the recommendation of the panel on February 22, Vivus shares more than doubled their value.
The FDA initially rejected Qsymia in October 2010, citing potential cardiovascular problems and more chances of cleft lips in children born to women who conceive while taking the drug. Mountain View, California-based Vivus then resubmitted Qsymia with longer-term data and analyzes.
The market for anti-obesity drugs is virtually untapped, with a host of drugs failing to find favor with the FDA.
Obesity, a public health epidemic, is growing at an alarming rate. The CDC estimates that more than one-third of U.S. adults (35.7 percent) and about 17 percent (or 12.5 million) of children and adolescents aged 2-19 years are obese. According to a new report, 42 percent of Americans could be obese by 2030.
According to market research firm Global Industry Analysts Inc., the global market for anti-obesity drugs is projected to reach $10.3 billion by the year 2017.
The drug therapy for treatment of obesity has had a checkered past, and till date, there has been no 'silver bullet' remedy for obesity. Some approved pills like Abbott's (ABT) Meridia have been pulled from the U.S. market due to safety concerns.
VVUS closed Tuesday's regular trading session at $26.46, down $2.24 or 7.82% on a volume of over 19.02 million shares. In after hours, the stock lost a further $1.81 or 6.84%. In the past year, the stock ranged between $6.13 and $29.99.
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by RTT Staff Writer
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