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FDA won’t OK prescription weight-loss drug Qnexa

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The Food and Drug Administration has declined to approve the prescription weight-loss drug Qnexa, but the company that developed it said it remains hopeful that the medication will reach the marketplace eventually.

The FDA denial, issued Thursday, wasn’t a surprise because an advisory committee voted against approving the drug in July. However, in an investors’ conference call Friday, officials for Vivus said they are “encouraged” that they can address the agency’s concerns.

The federal agency has asked the company to provide additional data about whether Qnexa — a combination of two existing drugs, phentermine and topiramate — can cause birth defects and to quantify what that risk might be. The FDA has also requested data on whether the slight increase in heart rate linked to the drug increases the risk of heart attacks, strokes and other cardiovascular events.

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“We believe sufficient data exist to address the questions and no additional studies are required,” said Leland Wilson, chief executive of Vivus in Mountain View, Calif.

Vivus last month released data from a two-year study of 4,323 patients showing there was no increased risk of cardiovascular events among those who took Qnexa, compared with those who took a placebo. The data show that people on the drug have an average weight loss of at least 10% of total body weight, along with improvements in blood pressure, according to Vivus.

“In the end the right decision will be made,” Wilson said.

This has not been a good year for progress on new medications to help overweight and obese Americans. Last week, the FDA informed Arena Pharmaceuticals that it would not approve its new drug, Lorcaserin, due to concerns about its marginal effectiveness and about cancers that occurred at higher-than-usual rates during clinical trials.

And this month, Abbott Laboratories said it would withdraw its diet drug Meridia from the market at the FDA’s request and after members of an advisory panel expressed concern about its safety. A study found that Meridia increases the risk of heart attacks and strokes in people with cardiovascular disease.

shari.roan@latimes.com

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