Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee
Thu, 11/05/2009 - 4:14am
Theratechnologies today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration ("FDA") will review Theratechnologies' NDA for tesamorelin in the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The role of the Advisory Committee, which is tentatively scheduled to meet with Theratechnologies during the first quarter of 2010, is to provide the FDA with independent opinions on the use of tesamorelin from medical experts, patient groups and various stakeholders. "We view the solicitation of additional viewpoints from various external groups as positive and over the next few months we will work together with the FDA to prepare for the meeting," noted Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies. As part of the FDA review process, the primary role of an Advisory Committee is to provide independent advice that will contribute to the quality of the agency's regulatory decision-making process. In the situation where a first-of-a-kind medical product, like tesamorelin, is evaluated for human use, it is common procedure to refer such a drug to an Advisory Committee prior to making a decision as stated in the FDA regulations. Although Advisory Committees provide their opinions to the Agency during publicly held meetings, the final decisions on marketing approvals are made by FDA. Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. The FDA filed the NDA on August 12, 2009, which initiated a substantive review of the application.