The FDA yesterday rejected drugmaker Vivus’ application to market the weight-loss drug Qnexa, a combination of two existing drugs, phentermine and topiramate. It’s the third setback for a weight-loss drug this month: The FDA last week declined to approve a different drug, lorcaserin, because it caused tumors in rats and earlier forced Meridia off the market because it caused an increased risk of heart attack and stroke in patients with a history of heart disease.
The FDA did not explain why it rejected the drug, but Vivus said the agency had asked for information about its potential to cause birth defects and heart problems. It said it could provide the information in six weeks, and if the agency is satisfied, the drug could be approved next year.
”It’s gotten to the point where the FDA won’t approve anything anymore if there’s any risk involved,” says ACSH’s Dr. Josh Bloom. “The rate of approval of new drugs has gone down precipitously in the last decade. In 1996 there were 53 new drugs approved. In the past five years, the average has been about 23. I find it hard to believe that potential new drugs have gotten twice as dangerous in the last 14 years.”
One last proposed diet drug, Orexigen Therapeutics’ Contrave, is scheduled to go before an FDA advisory committee in December.