Theratechnologies announced that the US Food and Drug Administration (FDA) has confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee will meet to review Theratechnologies' New Drug Application (NDA) for tesamorelin on Thursday, May 27, 2010. The meeting will take place at The Inn and Conference Center, University of Maryland University College (3501 University Blvd. East, Adelphi, Maryland).
Theratechnologies submitted an NDA to the US FDA on May 29, 2009, for tesamorelin, an analogue of the human growth hormone releasing factor proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The US FDA filed the NDA on August 12, 2009, which initiated a substantive review of the application. The Advisory Committee meeting was originally scheduled for February 24, 2010, but was postponed due to administrative delays at the US FDA. As a result of this postponement, the US FDA has indicated that the action goal date, which is the target date for the FDA to complete its review of the tesamorelin NDA, will be extended to July 27, 2010.
Several factors including a patient's antiretroviral drug regimen and the HIV virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance.
Theratechnologies is a Canadian biopharmaceutical company that discovers and develops innovative therapeutic products, with an emphasis on peptides, for commercialization.