Egrifta
Generic name: tesamorelin
Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy
Tesamorelin NDA Accepted for Filing
U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application for tesamorelin
Montreal, Canada – August 12, 2009 – Theratechnologies today announced that the US Food and Drug Administration ("FDA") has accepted to file the New Drug Application ("NDA") made by the Company for its lead compound, tesamorelin. Under the terms of the Company’s collaboration and licensing agreement with EMD Serono, Inc., the acceptance to file tesamorelin NDA is associated with a milestone payment of US $10 million (approximately CAN $11 million).
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 acceptance to file the NDA means that FDA will now begin its substantive review of the application.
About HIV-Associated Lipodystrophy
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. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients.
About Theratechnologies
Theratechnologies is a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the human growth hormone releasing factor.
In late 2008, Theratechnologies completed its Phase 3 clinical program which was designed to evaluate tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy. Theratechnologies signed a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States.
Theratechnologies’ growth strategy is firmly focused on the development of tesamorelin in the United States and in other potential lipodystrophy markets, as well as through additional clinical programs for other medical conditions.
Contact:
Andrea Gilpin Vice President, IR & Communications Theratechnologies Inc. Phone: 514 336-7800, ext. 205 communications@theratech.com
Aline Vandermeer Coordinator, IR & Communications Theratechnologies Inc. Phone: 514 336-7800, ext. 229 avandermeer@theratech.com
Posted: August 2009
Related articles
- FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy - November 11, 2010
- Theratechnologies: Update on timeline for FDA Action Date - July 22, 2010
- Theratechnologies announces positive vote by FDA Advisory Committee for tesamorelin - June 7, 2010
- FDA Confirms Date for Advisory Committee Review of the Tesamorelin New Drug Application - March 22, 2010
- Theratechnologies Announces a Tentative New Date for the FDA Advisory Committee Review of the tesamorelin New Drug Application - February 25, 2010
- Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee - November 5, 2009
- Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration - June 3, 2009
Egrifta (tesamorelin) FDA Approval History
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