Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

11/11/10