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FDA panel backs Vivus' weight loss drug

Qnexa could be first new obesity drug approved in the US in 13 years

A US Food and Drug Administration (FDA) advisory committee has voted in favour of approving Vivus' weight-loss drug Qnexa, raising the prospects of authorisation in April.

The panel voted 20-2 to recommend approval of Qnexa (phentermine/topiramate) on the grounds that its benefits outweighed the risks of therapy. The FDA turned down Vivus' marketing application for the drug in 2010 after the panel voted narrowly against approval.

If given the go-ahead, Qnexa would be the first new obesity drug to be approved in the US in 13 years, and enter a market which is underserved by pharmacologic treatments following a series of product withdrawals and failed development programmes.

In the 1990s, the value of drug treatment for obesity took a severe knock after one widely-used regimen (fenfluramine and phentermine or 'fen-phen') was found to raise the risk of heart valve defects and pulmonary hypertension.

The treatment was taken off the market, leading to a wave of product liability lawsuits.

Since then several other drugs have struggled to win marketing approval for weight loss including Orexigen Therapeutics' Contrave (bupropion/naltrexone) , Arena Pharmaceuticals/Eisai's lorcaserin and Sanofi's Acomplia (rimonabant), which was approved in the EU but taken off the market in in 2008 after being linked to depression.

Another widely-used drug - Abbott Laboratories' Reductil/Meridia (sibutramine) - was taken off the market in 2010 after it was linked to an increased risk of myocardial infarction and stroke.

That attrition rate means that, at present, Roche's Xenical (orlistat) is the only FDA-approved weight loss medicine in the US, although Orexigen and Arena are still trying to get their drugs approved in the country.

Panellists debated whether Vivus should carry out a heart risk study for Qnexa - something which may be mandated for all weight-loss drugs in future - and whether this should be before or after approval.

Vivus' drug has been linked to an increase in heart rate, leading to concerns it could raise the risk of cardiovascular side effects in some patients.

Vivus has already said it would commit to conducting a post-approval study in more than 11,000 patients that would look at Qnexa's potential to reduce heart complications in obese, at-risk patients.

It is also carrying out a study to examine the risk of oral cleft birth defects among children whose mothers had taken topiramate in the early stages of pregnancy, but that data is not due until after the FDA's April 17 review deadline.

23rd February 2012

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Rainmaker is an independent, award-winning communications agency with offices in London and Atlanta. Our experience across pharmaceuticals, generics, OTC, medical...

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