THTX : FDA Oks EGRIFTA WR To Treat Excess Visceral Abdominal Fat In Adults With HIV & Lipodystrophy

(RTTNews) - Theratechnologies Inc. (THTX, TH.TO) announced that the U.S. Food and Drug Administration has approved the company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The company will commercialize the new formulation under the tradename EGRIFTA WR.

According to the company, Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The new formulation, EGRIFTA WR, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation, sold in the U.S. as EGRIFTA SV, which is reconstituted daily.

The most commonly reported adverse reactions of EGRIFTA WR include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.

The company noted that EGRIFTA WR will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. The product can be stored at room temperature before and after reconstitution.

EGRIFTA WR will be manufactured at a new, U.S.-based contract drug manufacturing organization (CDMO). The new formulation, which is patent protected in the U.S. until 2033, is set to replace EGRIFTA SV.

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