Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin. The Company will address the FDA's request and intends to pursue approval of this new formulation of Tesamorelin. The questions outlined in the CRL are largely related to chemistry, manufacturing and controls (CMC) concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted drug product.

In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk. The Company will continue to commercialize EGRIFTA SV, which is the only approved treatment in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. 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) 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 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 tumor, 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 to EGRIFTA SV include: hypersensitivity reactions, hyperglycemia, injection site reactions, arthralgia, pain in extremity, myalgia and peripheral edema.