FDA Gives ‘Go-Ahead’ Signal to Egrifta Drug

The US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee have collectively supported the approval of tesamorelin acetate (Egrifta from Theratechnologies, Inc., Montreal) to stimulate and sustain a lessening of surplus visceral abdominal fat in HIV-tainted patients with lipodystrophy.

The committee based its consent on figures submitted by the supporter, which revealed that 57% of patients having tesamorelin faced an 8% or higher decrease in abdominal fat compared than 29% of patients on placebo.

The group was also affected by "compelling" statement by 2 HIV-positive victims who told them that how demoralizing it was to live with the ugly pot belly, an unfavorable result of antiretroviral therapy, which at once tagged them as "AIDS patients".

All the 16 members of the jury, one by one gave their rationales for giving a thumbs up to the drug. Every one said that the backer unmistakably demonstrated what they had wanted to show.

Abraham Thomas, MD, MPH, Division Head of Endocrinology, Diabetes, Bone and Mineral Disorders, Henry Ford Hospital, Detroit, Michigan said, "I voted yes and it was an easy decision. The sponsor was asked to show a reduction of visceral adipose tissue and they did that".

He said that they exhibited an enhancement in patients' view of their body shape, that patients felt good concerning their appearance.