Theratechnologies’ Tesamorelin HIV Drug On the Road to FDA Approval

The FDA advisory panel has unanimously agreed that a drug designed to reduce belly fat in HIV patients is safe to distribute. The FDA will still have the final decision, but typically, they follow the panel’s recommendations. The decision is due by July 27th. The approval recommendation has been based on drug trials that produced favorable results.

Theratechnologies tested their HIV drug named tesamorelin. The drug is designed to treat a condition known as lipodystrophy. Lipodystrophy is the accumulation of belly fat that many people experience as a side effect when taking antiretroviral drugs for HIV. Patients are often discouraged by the excessive belly fat and suffer a lower self-esteem as a result. 2 HIV positive patients expressed their devastation about dealing with the belly fat and unintentionally identifying themselves as HIV positive. Their testimony helped convince several panel members the benefits outweighed the modest risks associated with tesamorelin. The panel did express its concern about the increased risk of developing diabetes while taking the drug.

Two separate studies were conducted that included 816 participants that were either given a placebo or tesamorelin. In total, 543 patients received the tesamorelin, while the rest took the placebo for six months. At the end of the six months, the patients originally on the placebo were given tesamorelin. The tesamorelin patients were either given a placebo or continued on the tesamorelin for an additional six months. Patients receiving tesamorelin had an average of 17.5 percent reduction in belly fat. The effects of the drug are temporary and a patient would need to keep taking the medicine to see positive results.