Phase III data paves way for Theratechnologies’ NDA

Theratechnologies is heralding positive Phase III data for its lead program--tesamorelin--for HIV-associated lipodystrophy. After 26 weeks of treatment in the confirmatory study, researchers said that volunteers demonstrated an average 11 percent reduction in fat in the belly cavity. The data hit the study's primary endpoint and key secondary endpoints.

"In this second Phase 3 trial, tesamorelin is again proving to be efficacious at reducing VAT (visceral adipose tissue), without reducing subcutaneous adipose tissue, while being well tolerated in patients," said Yves Rosconi, CEO of Theratechnologies. "These confirmatory data are critical to the (U.S.) new drug application submission that is in preparation to obtain market approval for tesamorelin."

- check out this release for more
- read the report from the Canadian Press