Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
Theratechnologies (NASDAQ: THTX) has received FDA approval for EGRIFTA WR™, an improved formulation of tesamorelin for treating excess visceral abdominal fat in adults with HIV and lipodystrophy. The new formulation requires weekly reconstitution instead of daily, with less than half the administration volume compared to the current EGRIFTA SV® version.
EGRIFTA WR™ will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg injected subcutaneously and can be stored at room temperature. The product is patent protected in the U.S. until 2033 and will be manufactured at a new U.S.-based contract drug manufacturing organization.
Common adverse reactions include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. The new formulation has shown bioequivalence to the original F1 formulation of tesamorelin.
Theratechnologies (NASDAQ: THTX) ha ricevuto l'approvazione della FDA per EGRIFTA WR™, una formulazione migliorata di tesamorelin per il trattamento dell'eccesso di grasso viscerale addominale negli adulti con HIV e lipodistrofia. La nuova formulazione richiede una ricostituzione settimanale invece di quella giornaliera, con meno della metà del volume di somministrazione rispetto all'attuale versione EGRIFTA SV®.
EGRIFTA WR™ sarà fornito in quattro flaconcini monouso, ciascuno contenente 11,6 mg di tesamorelin, sufficienti per sette dosi. La dose giornaliera è di 1,28 mg iniettata sottocutaneamente e può essere conservata a temperatura ambiente. Il prodotto è protetto da brevetto negli Stati Uniti fino al 2033 e sarà prodotto presso una nuova organizzazione di produzione farmaceutica con sede negli Stati Uniti.
Le reazioni avverse comuni includono artralgia, reazioni nel sito di iniezione, dolore agli arti, edema periferico e mialgia. La nuova formulazione ha mostrato bioequivalenza rispetto alla formulazione originale F1 di tesamorelin.
Theratechnologies (NASDAQ: THTX) ha recibido la aprobación de la FDA para EGRIFTA WR™, una formulación mejorada de tesamorelin para tratar el exceso de grasa abdominal visceral en adultos con VIH y lipodistrofia. La nueva formulación requiere una reconstitución semanal en lugar de diaria, con menos de la mitad del volumen de administración en comparación con la versión actual EGRIFTA SV®.
EGRIFTA WR™ se suministrará en cuatro viales de un solo uso por paciente, cada uno conteniendo 11.6 mg de tesamorelin, suficiente para siete dosis. La dosis diaria es de 1.28 mg inyectados subcutáneamente y se puede almacenar a temperatura ambiente. El producto está protegido por patente en EE. UU. hasta 2033 y será fabricado en una nueva organización de fabricación de medicamentos con sede en EE. UU.
Las reacciones adversas comunes incluyen artralgia, reacciones en el sitio de inyección, dolor en las extremidades, edema periférico y mialgia. La nueva formulación ha mostrado bioequivalencia con la formulación original F1 de tesamorelin.
Theratechnologies (NASDAQ: THTX)는 HIV와 지방이영양증이 있는 성인의 복부 내장 지방 과다를 치료하기 위한 tesamorelin의 개선된 제형인 EGRIFTA WR™에 대해 FDA 승인을 받았습니다. 새로운 제형은 기존 EGRIFTA SV® 버전과 비교하여 관리 볼륨이 절반 이하로 줄어들고 매일 재구성이 아닌 매주 재구성이 필요합니다.
EGRIFTA WR™는 각각 11.6mg의 tesamorelin이 포함된 4개의 단일 환자 사용 바이알로 제공되며, 7회 분량에 충분합니다. 하루 복용량은 피하 주사로 1.28mg이며 실온에서 보관할 수 있습니다. 이 제품은 2033년까지 미국에서 특허로 보호되며, 미국에 본사를 둔 새로운 계약 제약 제조 조직에서 제조될 것입니다.
일반적인 부작용으로는 관절통, 주사 부위 반응, 사지 통증, 말초 부종 및 근육통이 있습니다. 새로운 제형은 tesamorelin의 원래 F1 제형과 생물학적 동등성을 보여주었습니다.
Theratechnologies (NASDAQ: THTX) a reçu l'approbation de la FDA pour EGRIFTA WR™, une formulation améliorée de tesamorelin pour le traitement de l'excès de graisse abdominale viscérale chez les adultes atteints de VIH et de lipodystrophie. La nouvelle formulation nécessite une reconstitution hebdomadaire au lieu quotidienne, avec moins de la moitié du volume d'administration par rapport à la version actuelle EGRIFTA SV®.
EGRIFTA WR™ sera fourni sous forme de quatre flacons à usage unique, chacun contenant 11,6 mg de tesamorelin, suffisant pour sept doses. La dose quotidienne est de 1,28 mg injectée par voie sous-cutanée et peut être conservée à température ambiante. Le produit est protégé par un brevet aux États-Unis jusqu'en 2033 et sera fabriqué par une nouvelle organisation de fabrication de médicaments basée aux États-Unis.
Les réactions indésirables courantes comprennent l'arthralgie, les réactions au site d'injection, la douleur dans les membres, l'œdème périphérique et la myalgie. La nouvelle formulation a montré une bioéquivalence par rapport à la formulation originale F1 de tesamorelin.
Theratechnologies (NASDAQ: THTX) hat die FDA-Zulassung für EGRIFTA WR™, eine verbesserte Formulierung von Tesamorelin zur Behandlung von übermäßigem viszeralem Bauchfett bei Erwachsenen mit HIV und Lipodystrophie, erhalten. Die neue Formulierung erfordert eine wöchentliche Rekonstitution anstelle einer täglichen, mit weniger als der Hälfte des Verabreichungsvolumens im Vergleich zur aktuellen EGRIFTA SV®-Version.
EGRIFTA WR™ wird in vier Einmalgebrauch-Glasfläschchen geliefert, die jeweils 11,6 mg Tesamorelin enthalten und für sieben Dosen ausreichen. Die tägliche Dosis beträgt 1,28 mg, die subkutan injiziert wird und bei Raumtemperatur gelagert werden kann. Das Produkt ist in den USA bis 2033 durch Patente geschützt und wird von einer neuen, in den USA ansässigen Vertragsarzneimittelherstellungsgesellschaft hergestellt.
Häufige Nebenwirkungen sind Arthralgie, Reaktionen an der Injektionsstelle, Schmerzen in den Extremitäten, periphere Ödeme und Myalgie. Die neue Formulierung hat eine Bioäquivalenz zur ursprünglichen F1-Formulierung von Tesamorelin gezeigt.
- FDA approval received for improved drug formulation
- Weekly reconstitution instead of daily administration improves patient convenience
- Patent protection until 2033 ensures market exclusivity
- New U.S.-based manufacturing facility established
- Long-term cardiovascular safety not established
- No data supporting improved compliance with anti-retroviral therapies
- Multiple contraindications and adverse reactions reported
Insights
The FDA approval of EGRIFTA WR™ (Tesamorelin F8) represents a significant formulation improvement over Theratechnologies' existing product. This isn't simply a cosmetic change - the weekly reconstitution (versus daily for the current version) addresses a major compliance barrier in chronic medication adherence. The reduced administration volume and room temperature storage further enhance the patient experience.
From a regulatory perspective, achieving bioequivalence to the original formulation was critical, as it allowed Theratechnologies to pursue the more streamlined supplemental Biologics License Application (sBLA) pathway rather than a completely new application. This strategy saved years of development time and millions in clinical trial costs.
The approval strengthens Theratechnologies' market position in the HIV lipodystrophy space, where they maintain exclusivity as the only FDA-approved treatment for excess abdominal fat in adults with HIV who have lipodystrophy. The extension of patent protection until 2033 provides substantial commercial runway.
The manufacturing transition to a U.S.-based CDMO likely addresses supply chain resilience concerns that have become increasingly important in biopharmaceutical manufacturing. While the safety profile remains consistent with previous formulations (arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia), the reduced administration burden may improve overall risk-benefit perception among prescribers and patients.
This FDA approval delivers multiple value drivers for Theratechnologies that strengthen its commercial position. First, the patent protection through 2033 secures this revenue stream for over eight years, providing essential long-term visibility for a small-cap biopharmaceutical company (
The transition to weekly reconstitution from daily preparation represents a substantial convenience improvement that could drive better therapy adoption and persistence. Improved adherence typically translates to better health outcomes, which can strengthen reimbursement positioning with payers.
Moving manufacturing to a U.S.-based contract drug manufacturing organization offers potential benefits in supply chain security, though cost implications aren't specified. For specialty medications like EGRIFTA, reliable manufacturing is particularly crucial given the patient population.
While this approval doesn't expand Theratechnologies' addressable market, it significantly reinforces their competitive moat in the HIV lipodystrophy space by enhancing product attributes while maintaining therapeutic equivalence. For investors, this represents successful lifecycle management that extends the commercial viability of a key product.
The stock should respond positively to this news as it demonstrates both regulatory execution capability and commitment to product improvement in their core therapeutic area. The company has effectively extended its exclusive market position in treating excess abdominal fat in adults with HIV who have lipodystrophy.
New, improved formulation set to replace EGRIFTA SV®
MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License 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 healthcare providers more effectively manage comorbidities like lipodystrophy, which today often presents as central adiposity,” said Christian Marsolais, Ph.D., 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 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. The product can be stored at room temperature (20° to 25° C [68° to 77° F]) 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 antiretrovirals 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 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 F8 formulation; (ii) the experience of using the F8 formulation for patients; and (iii) the transition to the F8 formulation from EGRIFTA SV®. 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 EGRIFTA SV®; and (ii) the F8 formulation of tesamorelin for injection will be reimbursed by private and public payors. 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 F8 formulation of tesamorelin for injection; (ii) the F8 formulation of tesamorelin for injection does not get reimbursement coverage from private and/or public payors; and (iii) the transition to the F8 formulation is delayed due to various matters, including delays associated with the availability of materials required to commercialize the F8 formulation. 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:
Joanne Choi
Senior Director, Investor Relations
jchoi@theratech.com
1-551-261-0401
FAQ
What are the key advantages of EGRIFTA WR™ over EGRIFTA SV® for HIV patients?
How long is THTX's patent protection for EGRIFTA WR™ in the United States?
What is the recommended dosage for EGRIFTA WR™?
What are the main side effects reported for EGRIFTA WR™?
Is EGRIFTA WR™ approved for weight loss management in HIV patients?
