FDA approves supplemental BLA for the F8 formulation of tesamorelin (Egrifta WR) for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.- Theratechnologies Inc.

 Theratechnologies Inc. announced that the  FDA 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.

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 s 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 SVC which is reconstituted daily. Pharmacokinetic studies have shown bioequivalence of Egrifta WR to the original F1 formulation of tesamorelin for injection (previously sold under the trade name Egrifta). The most commonly reported adverse reactions of Egrifta WR include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.

“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 (20° to 25° C [68° to 77° F]) before and after reconstitution.

“Central adiposity, characterized by the accumulation of excess visceral abdominal fat (EVAF), is a common complication for people with HIV that may result from the virus itself, from certain older antiretrovirals and from a reduction in growth hormone concentrations,” commented David Alain Wohl, MD, Professor at the Institute of Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill. “Given the significant impact of EVAF on health and quality of life for many of our patients with HIV, and the importance of maintaining lean muscle mass especially as we age, a new, more conveniently dosed formulation of tesamorelin is a welcome advancement.