by
Kyle Deighan
Last Wednesday, FDA's
Endocrinologic and Metabolic Drugs Advisory Committee recommended that the FDA approve the weight-loss drug
Qnexa® (phentermine and topiramate . The same panel, however, voted in 2010 to reject the drug over concerns about the drug's side effects. If allowed, Qnexa® would be the first FDA-approved anti-obesity drug in more than a decade. Qnexa® and FDA's approval standards for weight loss therapies were a hot topic recently at Leerink Swann's Global Healthcare Conference, as we reported
here.
Qnexa®, developed by
Vivus, Inc., is designed to decrease appetite and increase satiety, or the feeling of being full. It is a combination of two generic drugs--phentermine, an appetite suppressant, and topiramate, believed to increase satiety. Vivus states on its website that in phase 2 and 3 trials, patients taking Qnexa® have "demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program."
Peter Tam, President of Vivus
said, "We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa . . . We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic."
However, serious concerns remain about Qnexa®'s potential side effects, including heart problems and birth defects.
Mitchell S. Roslin, M.D., chief of bariatric surgery at Northern Westchester Hospital in New York, for instance,
noted, "[W]e don't know if this drug is safe enough for patients to stay on it to maintain their weight loss . . . It clearly works better than other drugs out there, but the questions remain -- at what cost and for how long." Additionally, there are those who doubt the drug's ability to cure obesity at all.
(Reuters - Regulators have rejected a move by AstraZeneca that could have delayed the entry of generic versions of its top-selling antipsychotic Seroquel onto the U.S. market later this month.
Britain's second biggest drugmaker said on Friday the Food and Drug Administration had denied its Citizen Petitions requesting the agency withhold finally approving any generic with labeling that did not have certain warning language required for its branded version.
Generic copies of the original instant-release form of Seroquel, or quetiapine, are due to hit the market on March 26 when AstraZeneca's patent expires.
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