US FDA approves second diet pill, Vivus' Qsymia

In a much anticipated but largely expected decision, the US Food and Drug Administration yesterday approved Vivus’ (Nasdaq: VVUA) weight loss drug Qsymia (phentermine and topiramate extended-release; formerly known as Qnexa). After not approving a new diet drug for 13 years, this follows the clearance of Arena and Eisai’s Belviq (lorcaserin) just three weeks ago (The Pharma Letter June 28).

Qsymia (renamed at the request of the FDA to avoid confusion with other brand names) is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related co-morbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia).

"Qsymia is the first FDA-approved once daily combination treatment for patients struggling with obesity," said Peter Tam, president of Vivus. "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. We are pleased with FDA's decision today because patients and physicians now have another treatment option available to them. It is expected that Qsymia will be available in the fourth quarter of 2012," he added.