"Theratechnologies Inc a commercial-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its Supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will market the new formulation under the brand name EGRIFTA WR ™ .
Tesamorelin for injection is the only medication approved in the United States for the reduction of excess abdominal fat in adults living with HIV who have lipodystrophy. The new formulation, EGRIFTA WR TM , is a once-daily injection product requiring only weekly reconstitution. The administration volume required is less than half that of the current F4 formulation, sold in the United States as EGRIFTA SV ® , which requires daily reconstitution. Pharmacokinetic studies have demonstrated bioequivalence between the F8 formulation and the first F1 formulation of tesamorelin for injection (previously sold under the brand name EGRIFTA MD ). The most commonly reported adverse reactions of EGRIFTA WR TM include arthralgia, injection site reactions, extremity pain, peripheral edema, and myalgia.
“We are pleased to offer this improved and more convenient version of tesamorelin for injection to help people living with HIV and their healthcare providers more effectively manage comorbid conditions such as lipodystrophy, which today often presents as central adiposity,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “With EGRIFTA WR ™ , administration is simpler and the patient experience is better, and these are important considerations for people living with HIV.”
EGRIFTA WR ™ will be supplied as four vials for single-patient use, 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) and is to be injected subcutaneously. The product may 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 abdominal visceral fat, is a common complication in people living with HIV. It can be caused by the virus itself, by certain older antiretroviral drugs, and by decreased growth hormone levels,” said David Alain Wohl, MD, professor at the Institute of Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill, North Carolina. “Given the significant impact of excess abdominal visceral fat on the health and quality of life of many of our patients living with HIV, as well as the importance of maintaining lean muscle mass, especially with aging, this new formulation of tesamorelin in a more convenient dose is a welcome advancement.”
EGRIFTA WR TM will be manufactured under contract with a U.S.-based manufacturer. The new formulation, protected by a U.S. patent until 2033, will replace EGRIFTA SV MD.
Information about EGRIFTA WR TM , including complete prescribing information, instructions for use, and important safety information, is available here .
Important Safety Information
EGRIFTA WR ™ (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy*. EGRIFTA WR ™ is a growth hormone-releasing factor (GH-RF) analog that acts on pituitary cells in the brain to stimulate the production and secretion of endogenous growth hormone.
* Limits of use:
The long-term cardiovascular safety of EGRIFTA WR ™ has not been established. The risks and benefits of continuing treatment should be considered in patients who have not achieved a reduction in visceral adipose tissue.
EGRIFTA WR TM is not indicated for weight loss management, as it has a neutral effect on weight.
There are no data to support improved adherence to antiretroviral therapy in HIV-positive patients taking EGRIFTA WR TM .
Contraindications:
EGRIFTA WR TM should not be used in people who:
have a disruption of the hypothalamic-pituitary-adrenal (HPA) axis caused by hypophysectomy, hypopituitarism, a tumor or surgery affecting the pituitary gland, irradiation of the head, or head trauma;
have progressive cancer;
are allergic to tesamorelin or any other ingredient in EGRIFTA WR TM ;
are pregnant or planning to become pregnant.
The most commonly reported adverse reactions of EGRIFTA WR TM include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.