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, replacing EGRIFTA SV.

EGRIFTA WR is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA). 

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. It can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution.

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

EGRIFTA WR will be manufactured at a new U.S.-based contract drug manufacturing organization (CDMO). 

“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.