Theratechnologies Announces Availability of EGRIFTA WR™ (tesamorelin) for injection to Reduce Excess Abdominal Fat in Adults with HIV and Lipodystrophy
Theratechnologies (NASDAQ: THTX) has announced the commercial availability of EGRIFTA WR™, a new formulation of tesamorelin for injection, following FDA approval earlier this year. The drug is specifically indicated to reduce excess abdominal fat in adults with HIV and lipodystrophy.
The improved formulation offers significant advantages over EGRIFTA SV®, including weekly reconstitution instead of daily and less than half the injection volume. EGRIFTA WR™ is supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin for seven daily 1.28 mg injections, and can be stored at room temperature. The formulation is patent protected until 2033.
The company is facilitating patient transition through its Thera Patient Support® program, offering free training by dedicated Nurse Navigators. EGRIFTA SV® will remain available during a transitional period as managed care plans expand coverage for EGRIFTA WR™.
Theratechnologies (NASDAQ: THTX) ha annunciato la disponibilità commerciale di EGRIFTA WR™, una nuova formulazione iniettabile di tesamorelin, dopo l'approvazione della FDA avvenuta all'inizio dell'anno. Il farmaco è indicato specificamente per ridurre l'eccesso di grasso addominale negli adulti con HIV e lipodistrofia.
La formulazione migliorata offre vantaggi significativi rispetto a EGRIFTA SV®, tra cui la ricostituzione settimanale anziché giornaliera e un volume di iniezione inferiore di oltre la metà. EGRIFTA WR™ è fornito in quattro flaconi monouso per paziente, ciascuno contenente 11,6 mg di tesamorelin per sette iniezioni giornaliere da 1,28 mg, e può essere conservato a temperatura ambiente. La formulazione è protetta da brevetto fino al 2033.
L'azienda supporta il passaggio dei pazienti tramite il programma Thera Patient Support®, offrendo formazione gratuita erogata da Nurse Navigator dedicati. EGRIFTA SV® resterà disponibile per un periodo di transizione mentre i piani di assicurazione gestita estenderanno la copertura per EGRIFTA WR™.
Theratechnologies (NASDAQ: THTX) ha anunciado la disponibilidad comercial de EGRIFTA WR™, una nueva formulación inyectable de tesamorelina, tras la aprobación de la FDA a principios de este año. El fármaco está indicado específicamente para reducir el exceso de grasa abdominal en adultos con VIH y lipodistrofia.
La formulación mejorada ofrece ventajas significativas frente a EGRIFTA SV®, incluyendo la reconstitución semanal en lugar de diaria y un volumen de inyección menor a la mitad. EGRIFTA WR™ se suministra en cuatro viales de un solo uso por paciente, cada uno con 11,6 mg de tesamorelina para siete inyecciones diarias de 1,28 mg, y puede almacenarse a temperatura ambiente. La formulación está protegida por patente hasta 2033.
La compañía facilita la transición de los pacientes a través de su programa Thera Patient Support®, ofreciendo capacitación gratuita impartida por Nurse Navigators dedicados. EGRIFTA SV® permanecerá disponible durante un período de transición mientras los planes de atención gestionada amplían la cobertura de EGRIFTA WR™.
Theratechnologies (NASDAQ: THTX)는 올해 초 FDA 승인에 이어 주사형 테사모렐린의 새 제형인 EGRIFTA WR™의 상업적 공급을 발표했습니다. 이 약물은 HIV 및 지방이상증이 있는 성인의 복부 과잉 지방을 줄이는 데 특별히 적응증이 있습니다.
개선된 제형은 EGRIFTA SV®에 비해 일일 재구성 대신 주간 재구성과 주사량이 절반 이하로 감소하는 등 큰 장점을 제공합니다. EGRIFTA WR™는 환자 1인용 단회 사용 바이알 4개로 제공되며, 각 바이알에는 1.28 mg씩 7회 분의 테사모렐린 11.6 mg이 들어 있고 실온 보관이 가능합니다. 이 제형은 2033년까지 특허 보호를 받습니다.
회사는 전담 Nurse Navigator가 제공하는 무료 교육을 포함한 Thera Patient Support® 프로그램을 통해 환자의 전환을 지원합니다. 관리 의료 플랜이 EGRIFTA WR™의 보험 적용을 확대하는 동안 EGRIFTA SV®는 과도기 동안 계속 이용할 수 있습니다.
Theratechnologies (NASDAQ: THTX) a annoncé la disponibilité commerciale de EGRIFTA WR™, une nouvelle formulation injectable de tesamoreline, suite à l'approbation par la FDA plus tôt cette année. Le médicament est spécifiquement indiqué pour réduire l'excès de graisse abdominale chez les adultes vivant avec le VIH et présentant une lipodystrophie.
La formulation améliorée présente des avantages importants par rapport à EGRIFTA SV®, notamment la reconstitution hebdomadaire au lieu d'une reconstitution quotidienne et un volume d'injection inférieur à la moitié. EGRIFTA WR™ est fourni en quatre flacons à usage unique par patient, chacun contenant 11,6 mg de tesamoreline pour sept injections quotidiennes de 1,28 mg, et peut être conservé à température ambiante. La formulation est protégée par brevet jusqu'en 2033.
La société facilite la transition des patients via son programme Thera Patient Support®, proposant une formation gratuite assurée par des Nurse Navigators dédiés. EGRIFTA SV® restera disponible pendant une période de transition, le temps que les régimes de soins gérés étendent la couverture à EGRIFTA WR™.
Theratechnologies (NASDAQ: THTX) hat die kommerzielle Verfügbarkeit von EGRIFTA WR™, einer neuen injizierbaren Tesamorelin-Formulierung, bekanntgegeben, nachdem die FDA Anfang des Jahres die Zulassung erteilt hatte. Das Medikament ist speziell zur Verringerung von überschüssigem Bauchfett bei Erwachsenen mit HIV und Lipodystrophie indiziert.
Die verbesserte Formulierung bietet gegenüber EGRIFTA SV® erhebliche Vorteile, darunter die wöchentliche Rekonstitution statt täglicher und ein weniger als halb so großes Injektionsvolumen. EGRIFTA WR™ wird in vier Einmal-Ampullen pro Patient geliefert, die jeweils 11,6 mg Tesamorelin für sieben tägliche Injektionen à 1,28 mg enthalten, und kann bei Raumtemperatur gelagert werden. Die Formulierung ist bis 2033 patentgeschützt.
Das Unternehmen unterstützt den Patientenumstieg über das Programm Thera Patient Support®, das kostenlose Schulungen durch dedizierte Nurse Navigators anbietet. EGRIFTA SV® bleibt während einer Übergangszeit verfügbar, während die Managed-Care-Pläne die Erstattung für EGRIFTA WR™ ausweiten.
- New formulation requires only weekly reconstitution versus daily for EGRIFTA SV®
- Reduced injection volume by more than 50% compared to previous version
- Patent protection extends until 2033
- Room temperature storage capability both before and after reconstitution
- Free patient support program available for transition
- Long-term cardiovascular safety not established
- Limited efficacy data - patients without visceral adipose tissue reduction may need to discontinue
- Multiple contraindications including active cancer and pregnancy
Insights
Theratechnologies' EGRIFTA WR™ launch enhances treatment convenience for HIV patients with lipodystrophy through reduced injection frequency and volume.
Theratechnologies has announced the commercial availability of EGRIFTA WR™ (tesamorelin), the next-generation formulation of their FDA-approved therapy for reducing excess abdominal fat in adults with HIV and lipodystrophy. This represents a significant advancement in patient convenience over the current EGRIFTA SV® product.
The key improvements in the new formulation include weekly reconstitution versus daily for the previous version, and less than half the injection volume. These changes directly address adherence challenges in chronic therapy administration - a critical factor in treatment effectiveness for long-term conditions.
From a clinical perspective, this remains the only FDA-approved medication specifically for excess abdominal fat in HIV patients with lipodystrophy, maintaining Theratechnologies' unique market position. The patent protection until 2033 provides substantial exclusivity runway, strengthening the company's long-term revenue prospects for this product line.
The transition strategy appears well-structured, with both formulations available during an insurance coverage transition period and support services to help patients switch to the new formulation. The Thera Patient Support® program with dedicated Nurse Navigators demonstrates commitment to patient experience beyond the product itself.
While not mentioned in the release, such formulation improvements typically command premium pricing over legacy versions, potentially enhancing revenue per patient. However, ultimate commercial impact will depend on payer coverage expansion and patient conversion rates from EGRIFTA SV®.
EGRIFTA WR™ offers convenience of weekly reconstitution and reduced daily injection volume, compared to EGRIFTA SV®
Specialty pharmacies are now ordering EGRIFTA WR™ to fill prescriptions
MONTREAL, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced the availability of EGRIFTA WR™ (tesamorelin) for injection for the reduction of excess abdominal fat in adult patients with HIV and lipodystrophy. The announcement follows the approval of EGRIFTA WR™ by the U.S. Food and Drug Administration (FDA) earlier this year.
“Excess visceral abdominal fat is an increasingly important health concern for people living with HIV, and for the healthcare providers who treat them,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “With EGRIFTA WR™, we aim to simplify the management of excess visceral abdominal fat and enhance users’ experience, as part of our commitment to helping people with HIV live their best lives.”
The new, improved formulation of tesamorelin for injection – the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy – will gradually replace EGRIFTA SV®, the current formulation. Specialty pharmacies are now ordering EGRIFTA WR™ to fill prescriptions for the new formulation. EGRIFTA SV® will continue to be available during a transitional period as managed care plans increasingly provide coverage for EGRIFTA WR™.
EGRIFTA WR™ only needs weekly reconstitution and requires less than half the injection volume as EGRIFTA SV®, 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 WR™ can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution. The EGRIFTA WR™ formulation is patent protected in the U.S. until 2033.
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 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 SV® can enroll in the Thera Patient Support® program to help them transition to EGRIFTA WR™ 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 WR™.
“Our goal is to ensure a smooth transition to EGRIFTA WR™ for all eligible patients, and to safeguard their ongoing care,” Dr. Marsolais commented.
Further information about EGRIFTA WR™, including full prescribing information, instructions for use, and important safety information is available here.
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 tumor/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.
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. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
Refer to this link for the full prescribing information, patient information and instructions for use for EGRIFTA WR™.
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 at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and X.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, 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 SV® with EGRIFTA WR™. 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 WR™ 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 Company’s 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 WR™ does not get reimbursement coverage from private and/or public payors. The Company refers current and potential investors to the “Risk Factors” section of the Company’s annual information form filed under Form 20-F dated February 26, 2025 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ 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 Company’s 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
FAQ
What is EGRIFTA WR™ and what is it used for?
How does EGRIFTA WR™ differ from EGRIFTA SV®?
What are the main side effects of EGRIFTA WR™?
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How long is EGRIFTA WR™ patent protected?
