FDA Decision on Egrifta (Tesamorelin) Delayed Until Fall

By Myles Helfand

August 3, 2010

Myles is the editorial director of TheBody.com and TheBodyPRO.com.

It's been more than a month since a U.S. Food and Drug Administration (FDA) advisory panel unanimously recommended approval of Egrifta (tesamorelin). That recommendation appeared to put Egrifta firmly on track to become the first approved treatment for lipohypertrophy (unusual fat gain) in people with HIV.

It was widely expected that July 27 would be the big day, but it came and went with no approval. What gives?

What gave, apparently, was the FDA's willingness to approve the drug without a more stringent review. According to a press release from Theratechnologies, the company developing Egrifta, an official FDA decision has been pushed back until sometime between October and December of 2010. The company notes in the press release that, despite the hefty delay, the "FDA has indicated that the review is progressing well."

So what's the reason behind the delay? EMD Serono, the company marketing Egrifta in the U.S., declined to comment to TheBody.com, so any speculation would be an educated guess at best. But it's worth noting that during the FDA advisory committee meeting in May, a number of potential safety concerns were raised about Egrifta, including an apparent increased risk for diabetes among people taking the drug who were pre-diabetic. There's no doubt that Egrifta does what it claims to do -- reduce visceral adipose tissue, or excess abdominal fat, in people with HIV -- but some in the HIV community have been cautious in their assessment of the drug.

However, before we start making too many assumptions about Egrifta's safety, it's important to keep in mind that this delay could simply be about the FDA itself. Beginning with the Vioxx disaster earlier this decade and continuing through the Avandia mess just last month, there is a great deal of heat on the FDA to make as sure as it possibly can that new drugs don't have any hidden surprises when it comes to side effects. As a result, the agency has greatly slowed its rate of drug approvals this year as it grows more deliberate about its review process. Egrifta may well just be another drug whose approval has been delayed by a slower conveyor belt at the FDA.

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