Canada's Theratechnologies and partner Merck KGaA are celebrating after regulators in the USA gave the green light to a new treatment for excess fat in HIV patients.
Specifically, the US Food and Drug Administration has approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretrovirals used to treat HIV.
The approval is based on two clinical trials involving 816 HIV-infected adults with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period and in both studies experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving an injectable placebo. The FDA noted that some patients reported improvements in their self image.
Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor drug administered in a once-daily injection. The approval is not a surprise, given that the agency's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 in favour of the treatment at the end of May.
Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. said the agency recognises the need for therapies to treat patients with HIV-lipodystrophy. He added that the presence of excess fat with this condition may contribute to other health problems "as well as affect a patient's quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important".
Egrifta will marketed in the USA by Merck KGaA's EMD Serono unit.