ARTICLE | Regulation
Cutting the VAT
FDA panel: Quality of life key to Theratechnologies' Egrifta for HIV patients
May 31, 2010 7:00 AM UTC
The potential for Egrifta tesamorelin from Theratechnologies Inc. to improve quality of life in HIV patients with lipodystrophy was enough to sway an FDA panel that the candidate warrants approval despite a lack of evidence linking reductions in reducing abdominal fat to a cardiovascular benefit.
FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 last Thursday that the overall benefit-risk of Egrifta supported approval...