Mr. Philippe Dubuc reports

THERATECHNOLOGIES RECEIVES JANUARY 2024 PDUFA GOAL DATE FOR TESAMORELIN F8 FORMULATION SBLA

The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Jan. 22, 2024, to Theratechnologies Inc.'s supplemental biologics licence application (sBLA) of the F8 formulation of tesamorelin.

Tesamorelin is the only medication approved in the United States for the reduction of excess abdominal fat in adults with HIV (human immunodeficiency virus) who have lipodystrophy. Once approved, the F8 formulation is set to replace the current F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV. The proposed proprietary name for the F8 formulation of tesamorelin, EGRIFTA MDV, is already under review by the FDA.

In accordance with the FDA's standard review practices, unless the company is notified before Nov. 21, 2023, that the application is not sufficiently complete to permit a substantive review, the FDA will file the sBLA for the F8 formulation of tesamorelin.

About EGRIFTA SV (tesamorelin for injection)

EGRIFTA SV is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.* EGRIFTA SV is a growth hormone-releasing factor (GHRF) analogue 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 SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
• EGRIFTA SV 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 SV.

Do not use EGRIFTA SV if a patient:

• Has a pituitary gland tumour, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or head trauma;
• Has active cancer;
• Is allergic to tesamorelin or any of the ingredients in EGRIFTA SV;
• Is pregnant or planning to become pregnant.

The most commonly reported adverse reactions of EGRIFTA SV include: hypersensitivity reactions, hyperglycemia, injection site reactions, arthralgia, pain in extremity, myalgia and peripheral edema.

Refer to the EGRIFTA SV website for the full prescribing information, patient information and instructions for use for further details about this product.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

We seek Safe Harbor.