Theratechnologies (TSX:TH) announced Thursday that the U.S. FDA has approved Egrifta, an injectable treatment to reduce excess abdominal fat in HIV-infected patients with lipodystrophy, a condition that causes body composition changes due to the antiretroviral drug regimen for HIV and the virus itself.
The FDA approval of the medicine was based on two placebo-controlled phase 3 studies, consisting of 816 HIV-infected patients with excess abdominal fat, associated with lipodystrophy. The trials evaluated the percent change of visceral adipose tissue from baseline, as assessed by a CT scan, which showed a statistically significant mean decrease of 27cm2.
Theratechnologies said that the drug, which was developed by the company, will be commercialized in the U.S. by EMD Serono, an affiliate of Merck, under a licensing agreement signed by the two companies in 2008.
"Theratechnologies will continue to focus on signing partnerships outside of the United States in order to access additional markets for EGRIFTA," said chairman of Theratechnologies, Paul Pommier.
The company did, however, warn that there are limitations to the use of Egrifta, as the long-term cardiovascular safety was not studied, and therefore "careful consideration" should be taken when deciding whether the drug should be continued in patients that do not show a "clear efficacy response".
In addition, Egrifta is not indicated for weight loss management, Theratechnologies said.
Under the terms of the agreement with EMD Serono, FDA marketing approval will give Theratechnologies milestone payments totaling US$25 million.
The company said the FDA requested three post-marketing requirements, including a long-term observational safety study for Egrifta, the development of a new presentation of the same formulation, and a clinical trial to assess whether the drug has an impact on diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy.
Disclosure: no position