08:13 AM EST, 11/26/2024 (MT Newswires) -- Theratechnologies ( THTX ) on Tuesday said it has resubmitted its supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for the F8 formulation of tesamorelin, which has been approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

The resubmission addresses concerns raised in the FDA's January complete response letter regarding the initial F8 formulation sBLA filing. The agency requested clarifications largely related to chemistry, manufacturing and controls, and further information on immunogenicity risk.

The FDA will review the updated sBLA within four months of submission and Theratechnologies ( THTX ) expects a decision around the end of March. The new formulation is patent protected in the U.S. until 2033.