FDA Panel Endorses First New Diet Pill in a Decade
Regulators had previously ruled the medication was too great of a health risk.
| Posted Thursday, Feb. 23, 2012, at 10:11 AM
Photo by Philippe Huguen/AFP/Getty Images.
UPDATE: A panel of medical experts at the FDA voted overwhelmingly on Wednesday to endorse the controversial weight-loss pill Qnexa.
Though the FDA will come to its final ruling later this year, the agency generally follows the decisions of its advisory committee, meaning that Wednesday's endorsement likely clears the way for the first new prescription diet pill in more than a decade, the Los Angeles Times reports.
The 20-2 vote in favor overturns that same advisory committee's decision back in 2010 that the drug’s risks of heart problems and birth defects outweighed its potential weight-loss benefits.
Vivus Inc., the manufacturer of the drug, promised to address such health concerns by proposing strict procedures for the drug’s prescription, like restricting the drug's sale to registered pharmacies and ensuring that pregnant women on the drug commit to regular screenings.
Friday, Feb. 17: If at first you don't succeed, try, try again.
Bloomberg News reports that drugmaker Vivus is again attempting to convince federal regulators that its weight-loss pill, Qnexa, is safe. The FDA previously rejected Vivus' application in 2010, citing health risks including heart problems and birth defects.
A final decision is expected Wednesday. If the agency does approve Qnexa, it would become the first new prescription diet pill in more than a decade. Analysts say the drug could generate roughly $450 million in sales by 2015 if it is approved.
On Friday, the FDA released a staff report suggesting that Vivus' new analysis of the health risks was "somewhat reassuring" but nevertheless said that regulators may need more information before giving the green light.
Qnexa is a combination of amphetamine phentermine, a stimulant you may recognize from the now banned weight loss drug fen-phen, and topiramate, a common seizure medicine. The New York Times reports that some doctors have found a loophole by prescribing the two ingredients separately to obese patients.
Two other drug companies, Area Pharmaceuticals Inc. and Orexigen Therapeutics Inc., also saw their previous attempts to win federal approval of similar weight loss pills denied by the FDA. Both are also in the process of reapplying.
