EGRIFTA WRโข offers convenience of weekly reconstitution and reduced daily injection volume, compared to EGRIFTA SVยฎ
Specialty pharmacies are now ordering EGRIFTA WRโข to fill prescriptions
MONTREAL, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (โTheratechnologiesโ or the โCompanyโ) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced the availability of EGRIFTA WRโข (tesamorelin) for injection for the reduction of excess abdominal fat in adult patients with HIV and lipodystrophy. The announcement follows the approval of EGRIFTA WRโข by the U.S. Food and Drug Administration (FDA) earlier this year.
โExcess visceral abdominal fat is an increasingly important health concern for people living with HIV, and for the healthcare providers who treat them,โ said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. โWith EGRIFTA WRโข, we aim to simplify the management of excess visceral abdominal fat and enhance usersโ experience, as part of our commitment to helping people with HIV live their best lives.โ
The new, improved formulation of tesamorelin for injection โ the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy โ will gradually replace EGRIFTA SVยฎ, the current formulation. Specialty pharmacies are now ordering EGRIFTA WRโข to fill prescriptions for the new formulation. EGRIFTA SVยฎ will continue to be available during a transitional period as managed care plans increasingly provide coverage for EGRIFTA WRโข.
EGRIFTA WRโข only needs weekly reconstitution and requires less than half the injection volume as EGRIFTA SVยฎ, which is reconstituted daily. The product is supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven daily injections. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. EGRIFTA WRโข can be stored at room temperature (20ยฐ to 25ยฐ C [68ยฐ to 77ยฐ F]) before and after reconstitution. The EGRIFTA WRโข formulation is patent protected in the U.S. until 2033.
Pharmacokinetic studies have shown bioequivalence of EGRIFTA WRโข to the original F1 formulation of tesamorelin for injection (previously sold under the trade nameย EGRIFTAยฎ).ย The most commonly reported adverse reactions of tesamorelin for injection include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.
Individuals with HIV and lipodystrophy who are currently using EGRIFTA SVยฎ can enroll in the Thera Patient Supportยฎ program to help them transition to EGRIFTA WRโข as insurance coverage becomes available. The program, which is offered free of charge, includes a dedicated team of Thera Nurse Navigators who are available to train enrolled patients on the use of EGRIFTA WRโข.
โOur goal is to ensure a smooth transition to EGRIFTA WRโข for all eligible patients, and to safeguard their ongoing care,โ Dr. Marsolais commented.
Further information about EGRIFTA WRโข, including full prescribing information, instructions for use, and important safety information is available here.
Important Safety Information
EGRIFTA WRโขย (tesamorelin) for injection is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.ย EGRIFTA WRโขย 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 ofย EGRIFTA WRโขย has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
- EGRIFTA WRโขย 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 takingย EGRIFTA WRโข.
Contraindications:
Do not useย EGRIFTA WRโขย if a patient:
- Has disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.
- Has active cancer.
- Is allergic to tesamorelin or any of the ingredients inย EGRIFTA WRโข.
- Is pregnant or planning to become pregnant.
The most commonly reported adverse reactions of EGRIFTA WRโขย include: arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.
Healthcare 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. Visitย http://www.fda.gov/medwatchย or call 1-800-FDA-1088.
Refer toย this link for the full prescribing information, patient information and instructions for use forย EGRIFTA WRโข.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website atย www.theratech.com, on SEDAR+ atย www.sedarplus.caย and on EDGAR atย www.sec.gov. Follow Theratechnologies onย Linkedinย andย X.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, the โForward-Looking Statementsโ) within the meaning of applicable securities laws, that are based on managementโs beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as โmayโ, โwillโ, โshouldโ, โcouldโ, โpromisingโ, โwouldโ, โoutlookโ, โbelieveโ, โplanโ, โenvisageโ, โanticipateโ, โexpectโ and โestimateโ, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the convenience of the new formulation of tesamorelin; (ii) the experience of using the new formulation of tesamorelin for patients; and (iii) the replacement of EGRIFTA SVยฎ with EGRIFTA WRโข. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the marketplace will accept this new formulation of tesamorelin; (ii) EGRIFTA WRโข will be reimbursed by private and public payors; and (iii) no biosimilar version of tesamorelin will be approved by the FDA. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Companyโs control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to: (i) patients and physicians do not adopt the new formulation of tesamorelin; and (ii) EGRIFTA WRโข does not get reimbursement coverage from private and/or public payors. The Company refers current and potential investors to the โRisk Factorsโ section of the Companyโs annual information form filed under Form 20-F dated February 26, 2025 available on SEDAR+ atย www.sedarplus.caย and on EDGAR atย www.sec.govย under Theratechnologiesโ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Companyโs expectations as of that date.
The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
Contacts:
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
Investor Inquiries:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608
