Dr. Christian Marsolais reports

THERATECHNOLOGIES RECEIVES FDA APPROVAL FOR EGRIFTA WR™ (TESAMORELIN F8) TO TREAT EXCESS VISCERAL ABDOMINAL FAT IN ADULTS WITH HIV AND LIPODYSTROPHY

The United States Food and Drug Administration (FDA) has approved Theratechnologies Inc.'s supplemental biologics licence 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 health care providers more effectively manage comorbidities like lipodystrophy, which today often presents as central adiposity," said Christian Marsolais, PhD, 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 milligrams of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg (0.16 millilitre of the reconstituted solution) injected subcutaneously. The product can be stored at room temperature (20 degrees to 25 degrees Celsius (68 degrees to 77 degrees Fahrenheit) 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 anti-retrovirals 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.

Further information about Egrifta WR, including full prescribing information, instructions for use and important safety information, is available on-line.

Important safety information

Egrifta WR (tesamorelin for injection) is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Egrifta WR is a growth hormone- releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone.

Limitations of use:

• Long-term cardiovascular safety of Egrifta WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
• Egrifta WR is not indicated for weight loss management as it has a weight-neutral effect.
• There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking Egrifta WR.

Contraindications:

Do not use Egrifta WR if a patient:

• Has disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumour/surgery, head irradiation or head trauma;
• Has active cancer;
• Is allergic to tesamorelin or any of the ingredients in Egrifta WR;
• Is pregnant or planning to become pregnant.

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

Health care providers and patients are encouraged to report adverse events at 1-833-23THERA (1-833-238-4372). You are encouraged to report side effects of prescription drugs to the FDA.

About Theratechnologies Inc.

Theratechnologies is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care.

We seek Safe Harbor.