Theratechnologies Inc., a commercial-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (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™, 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. 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.

“We are pleased to offer this improved, more convenient version of tesamorelin for injection to help people with HIV and their healthcare providers more effectively manage comorbidities like lipodystrophy, which today often presents as central adiposity,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “EGRIFTA WR™ enables a simplified administration and an improved patient experience, which are important considerations for people living with HIV.”

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.”

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^®.