Canada’s Theratechnologies and partner Merck KGaA are celebrating after advisors to the US Food and Drug Administration gave a unanimously positive recommendation to the former’s Egrifta for the treatment of excess abdominal fat in HIV-infected patients.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 that Egrifta (tesamorelin) should be granted marketing approval to help HIV-infected patients with lipodystrophy, for which there is currently no approved treatment. The compound is a growth hormone-releasing factor analogue and will be Theratechnologies’ first drug to hit the market if the FDA gives the thumbs-up; the agency will complete its review by July 27.

Visceral abdominal tissue in HIV-infected patients, which affects about one-third of those on antiretrovirals, is different from the type of visceral fat in people who are obese. Experts have said that excess abdominal fat has a significant negative impact on quality of life and can lead to HIV patients discontinuing their treatment.

Theratechnologies chief executive Yves Rosconi said the committee’s recommendation “reinforces our belief that the tesamorelin benefit-risk profile seen in clinical trials in HIV-patients with excess visceral abdominal fat supports approval for this indication”. The Montreal-headquartered company licensed the US rights for Egrifta in October 2008 to Merck’s EMD Serono under a deal potentially worth $215 million, plus royalties.