Qnexa: Vivus States No EU Ruling Until September
Qnexa, the diet drug made by Vivus, may not see a decision by European Union regulators until September, according to a statement by the company on Tuesday.
Market Watch reports that the Committee of Medicinal Products for Human Use (CHMP) has rescheduled their decision regarding the Marketing Authorization Application (MAA) for the drug, which is supposed to help treat obesity. The company submitted a response to the CHMP for a Day 180 form, and has been invited to participate in an oral hearing, which is reprotedly customary for EMA approval.
Peter Tam, president of Vivus Inc, the manufacturer of Qnexa, stated:
“We appreciate the flexibility of the CHMP to work with us on the timing of the oral hearing and the scheduling in September. We look forward to presenting to the CHMP in September, but are currently focused on working with the FDA ahead of the July 17, 2012 PDUFA and the potential Qnexa launch in the U.S. in the second half of this year.”
According to Reuters, Vivus is also working closely with the U.S. Food and Drug Administration, ahead of their July 17th review date, hoping that the drug will be launched in the U.S. after approval in the second half of 2012. The Vivus drug is not the only experimental weight loss drugs seeking approval from the US FDA, even after they were initially rejected.
Along with Vivus, Arena Pharmaceuticals Inc and Orexigen Therapeutics have also been rejected when trying to have their obesity pills approved by the FDA.
Would you consider taking a diet pill to treat obesity, or would you choose to go with regular exercise and a good diet?