US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Theratechnologies' tesamorelin, a growth hormone releasing factor, by a 16 to 0 unanimous vote that should be granted marketing approval by the US FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favourable benefit-risk profile.
"We are pleased with the outcome of the Advisory Committee. This recommendation reinforces our belief that the tesamorelin benefit-risk profile seen in clinical trials in HIV-patients with excess visceral abdominal fat supports approval for this indication," commented Yves Rosconi, president and chief executive officer of Theratechnologies. "The Advisory Committee recommendation is another important step forward for the company. It is especially significant for those patients who suffer from this serious metabolic complication, where today no treatment option exists," Rosconi concluded.
Although advisory committees provide their recommendations to the Agency, the final decisions on marketing approvals are made by the US FDA. The US FDA has indicated that the action goal date, which is the target date for the US FDA to complete its review of the tesamorelin New Drug Application, will be July 27, 2010.
In 2008, Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany), for the exclusive commercialization rights to tesamorelin in the United States for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Tesamorelin is a novel, stabilized analogue of growth hormone releasing factor (GRF).
Theratechnologies is a Canadian biopharmaceutical company that discovers and develops innovative therapeutic products, with an emphasis on peptides, for commercialization.