The US Food and Drug Administration has extended the Prescription Drug User Fee Act date for its review of Vivus’ obesity drug Qnexa by three months.

Vivus, based in California, said the action date has been moved from April 17 to July 17 2012, but noted that the move represents a standard extension period.

Following a request from the FDA, Vivus submitted the Qnexa Risk Evaluation and Mitigation Strategy (REMS), which was considered a major amendment to the new drug application, hence the delay.

The FDA said it now needs more time to complete a full review of the drug which aids weight loss and helps maintain weight loss for obese or overweight patients with weight-related health problems such as hypertension, type 2 diabetes or dyslipidemia.

Vivus CEO Leland Wilson said, "The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February.

"We look forward to finalising our REMS with the FDA while we move forward with our commercialisation plans," added Wilson.

 

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