The U.S. advisory panel of medical experts voted 20 to 2 in favor, to endorse the weight-loss drug, Qnexa. The weight loss drug will now wait for the Food and Drug Administration to approve the prescription drug for obesity. If they approve, it will be the first time since 1999 that a weight loss pill has made it that far. The FDA results will be issued late in the year. They usually follow the recommendations of its advisory committees.
Jason Butler, JMP Securities’ said, “In our view, the resounding vote of confidence from yesterday’s FDA Advisory Committee meeting provides us with high confidence that Qnexa will be approved by the April 17th review date.”
A Jefferies analyst said in a note to clients, “We remain cautious, however, and believe the FDA may still require pre-approval cardiovascular safety testing for Qnexa and potentially for all obesity drugs.”
In the weight loss drug trial for Qnexa, researchers detected that it increased the heart rate slightly. They also noticed it will increase the risk of birth defects which typically lead to cleft lip in women who became pregnant while taking the drug.
Joe Nadglowski, chief executive of the Obesity Action Coalition and is for the approval of the weight loss pills Qnexa said, “The simple reality is, if you’re pregnant or planning on getting pregnant, it’s not the right drug for you.”
The drug manufacturer, Vivus Inc. (NASDAQ:VVUS) plans to control those concerns by having a very close monitored system in prescribing the weight loss pills Qnexa. They say in order to prevent any birth defects they plan to have patients who are taking the weight loss pill undergo monthly pregnancy tests. The company also plans to restrict the distribution to only registered pharmacies.
Vivus’ senior director of global medical affairs, Dr. Barbara Troupin told the advisory committee, “We will know who the prescribers are. We will know who has been trained. We are confident the Qnexa risk management program balances the safeguards while allowing access for appropriate patients.”
If Qnexa is approved by the FDA, the weight loss drug would be sold to people with a body mass index of 30 or above, or a BMI of 27 or above for people who also have weight-related health problems, such as diabetes or sleep apnea. A BMI of 25 to 29 indicates a person is overweight, and 30 or greater is considered obese.