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FDA decision on Vivus’ obesity drug delayed three months

Review date for Qnexa extended to July 17

The US Food and Drug Administration (FDA) has extended its review date for Vivus' obesity drug Qnexa by three months to July 17, 2012.

The delay follows a request from the US drug regulator for Vivus to submit further data concerning the risk and evaluation mitigation strategy (REMS) for the treatment, which would be the first new obesity drug available in the US in 13 years if approved.

This new data is considered a 'major amendment' to the new drug application (NDA) for Qnexa (phentermine/topiramate) from Vivus, meaning a required extension of the review period.

News of the delay comes only two months after an advisory committee to the FDA voted in favour of approving the drug by 20 votes to 2, on the grounds that its benefits outweighed the risks of therapy.

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

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

Qnexa had previously been declined for approval by the FDA in 2010 after the drug was linked to an increase in heart rate, leading to concerns it could raise the risk of cardiovascular side effects in some patients.

Vivus resubmitted data for the drug, emphasising its benefits, although FDA panellists have debated that the company should carry out a heart risk study for Qnexa, and whether this should be before or after approval.

The last time a weight loss drug to be approved in the US was 1999, with the FDA declining applications for such products as Arena/Eisai's lorcaserin and Orexigen's Contrave.

Arena and Eisai are moving closer to a positive decision from the FDA, however, with agency advisors to meet in May to reconsider the licence application for the drug.

10th April 2012

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