An expert advisory committee of the U.S. Food and Drug Administration (FDA) voted unanimously today to recommend approval of tesamorelin.

Tesamorelin, also known by its proposed brand name Egrifta, is being reviewed by the FDA as a potential treatement for HIV-associated lipodystrophy, an excess accumulation of abdominal fat that is a frequent side effect of antiretroviral therapy. 

Tesamorelin has been developed by the Montreal-based biopharmaceutical company Theratechnologies.  If approved by the FDA as a treatment for lipodystrophy, the drug would be marketed in the U.S. by EMD Serono, a unit of the German pharmaceutical company Merck KGaA.

The 16-0 vote in favor of approval by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee does not guarantee that the FDA will eventually approve tesamorelin.  The FDA is not legally obligated to follow the recommendations of its advisory committees.  However, it generally does.

The Beacon will be publishing a more complete report on the FDA committee’s deliberations and recommendation later today.  Until then, readers interested in the full details of today’s advisory committee meeting should consult the Beacon’s comprehensive liveblog of the event.