Theratechnologies Files SBLA For F8 Formulation Of Tesamorelin To FDA

(RTTNews) - Biopharmaceutical company Theratechnologies Inc. (THTX, TH.TO) announced it has filed a supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the U.S. Food and Drug Administration (FDA) for review.

Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

Pharmacokinetic studies have shown bioequivalence of the F8 formulation to the original F1 formulation of tesamorelin (EGRIFTA).

The F8 formulation is eight times more concentrated than EGRIFTA and two times more concentrated than the F4 formulation sold in the U.S. under the trade name EGRIFTA SV. This enables a smaller volume of administration as well as a new product presentation in a multiple-dose vial (MDV) that is reconstituted only once per week. The new formulation is patent protected in the U.S. until 2033.

In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date. The proposed proprietary name for the F8 formulation, EGRIFTA MDVTM, is already under review by the FDA.