F8 in HIV-Associated Excess Abdominal Fat
Theratechnologies completed the evaluation and development of a new formulation of tesamorelin, referred to as F8 Formulation. Based on internal studies, the F8 Formulation is bioequivalent to the original formulation of tesamorelin, or F1 Formulation, commercialized as EGRIFTA®. The F1 Formulation is still available in Canada but is no longer available in the United States where it has been replaced by EGRIFTA SV®. The F8 Formulation has a number of advantages over the current formulation of EGRIFTA SV®. Specifically, it is two times more concentrated resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted once per week. Similar to the current formulation of EGRIFTA SV®, the F8 Formulation is stable at room temperature, even once reconstituted.
In parallel, Theratechnologies is currently working on the development of a multi-dose pen injector to be used with the F8 Formulation. Theratechnologies intends to seek marketing approval of the pen in conjunction with the F8 Formulation. We plan to file a supplemental Biologics License Application (sBLA) with the United States Food and Drug Administration for the F8 Formulation and multi-dose pen injector in early 2022 for the treatment of lipodystrophy in people with HIV.