FDA committee clears Theratechnologies’ tesamorelin

An FDA advisory committee recommended by a 16-to-0 unanimous vote that Theratechnologies’ (TSX:TH) tesamorelin drug should be granted marketing approval by the FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favourable benefit-risk profile.

“This 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,” CEO Yves Rosconi said in a statement.  “This is is especially significant for those patients who suffer from this serious metabolic complication, where today no treatment option exists.”

The final FDA final decision on marketing approval for tesamorelin will be July 27, 2010.  EMD Serono, an affiliate of Germany’s Merck KGaA, has exclusive commercialization rights to market tesamorelin in the U.S.