Last month, the FDA approved Arena Pharmaceuticals’ Belviq (lorcaserin) — the first weight-loss drug to hit the market in over a decade. Now the agency is making headway in the fight to treat obesity as it approves Qsymia (formerly Qnexa), another weight loss drug.
Following the FDA’s rejection of its initial application in 2010 — over concerns that it was associated with adverse psychiatric and cardiovascular side effects — drug maker Vivus submitted further data demonstrating Qysmia’s safety and efficacy. In February, an FDA advisory panel ruled 20 to 2 in favor of the drug, on the condition that the company complete a post-marketing study to demonstrate its safety. In fact, the FDA is now requiring that Vivus complete 10 such studies to evaluate the drug’s long-term cardiovascular events, including heart attack and stroke.
Like Belviq, Qysmia is approved for use in patients with a BMI of 30 or more or those with a BMI of 27 or greater who suffer from at least one obesity-related comorbidity such as diabetes or hypertension.
ACSH staffers applaud the agency’s latest approval, since few effective weight loss pharmaceuticals currently exist on the market. “With more effective weight loss options now available, we hope that more people will be encouraged to use these drugs to their advantage,” says ACSH’s Dr. Elizabeth Whelan. “Finally the FDA is on board with helping people lose weight.”