US FDA approves Merck KGaA Egrifta to treat lipodystrophy in HIV patients and development plan for Bionovo's Menerba

The US Food and Drug Administration yesterday 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 antiretroviral drugs used to treat HIV.

Egrifta, which was developed by Canada-based Theratechnologies and marketed in the USA EMD Serono - a US subsidiary of German drug major Merck KGaA (MRK: DE), is the first FDA-approved treatment for lipodystrophy. It is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.

"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, Director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “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,” he added.