Theratechnologies Receives FDA Approval of Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA
Theratechnologies (NASDAQ: THTX) has received FDA approval for its Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV®. This approval enables unrestricted distribution of EGRIFTA SV®, eliminating previous discretionary product release requirements.
EGRIFTA SV® is currently the only FDA-approved treatment for reducing excess abdominal fat in adults with HIV and lipodystrophy. The FDA has also recently approved a new F8 formulation, EGRIFTA WR™, which will replace EGRIFTA SV® and offers improved patient convenience.
The medication works as a growth hormone-releasing factor (GHRF) analog, stimulating the production and release of endogenous growth hormone. Common side effects include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.
Theratechnologies (NASDAQ: THTX) ha ricevuto l'approvazione della FDA per il suo Supplemento di Approvazione Precedente (PAS) alla domanda di licenza biologica supplementare (sBLA) per EGRIFTA SV®. Questa approvazione consente la distribuzione illimitata di EGRIFTA SV®, eliminando i precedenti requisiti discrezionali per il rilascio del prodotto.
EGRIFTA SV® è attualmente l'unico trattamento approvato dalla FDA per ridurre il grasso addominale in eccesso negli adulti con HIV e lipodistrofia. La FDA ha recentemente approvato anche una nuova formulazione F8, EGRIFTA WR™, che sostituirà EGRIFTA SV® e offre una maggiore comodità per i pazienti.
Il farmaco agisce come un analogo del fattore di rilascio dell'ormone della crescita (GHRF), stimolando la produzione e il rilascio dell'ormone della crescita endogeno. Gli effetti collaterali comuni includono artralgia, reazioni nel sito di iniezione, dolore agli arti, edema periferico e mialgia.
Theratechnologies (NASDAQ: THTX) ha recibido la aprobación de la FDA para su Suplemento de Aprobación Prevista (PAS) a la solicitud de licencia biológica suplementaria (sBLA) para EGRIFTA SV®. Esta aprobación permite la distribución sin restricciones de EGRIFTA SV®, eliminando los requisitos de liberación discrecional del producto anteriores.
EGRIFTA SV® es actualmente el único tratamiento aprobado por la FDA para reducir el exceso de grasa abdominal en adultos con VIH y lipodistrofia. La FDA también ha aprobado recientemente una nueva formulación F8, EGRIFTA WR™, que reemplazará a EGRIFTA SV® y ofrece una mayor comodidad para los pacientes.
El medicamento actúa como un análogo del factor de liberación de la hormona del crecimiento (GHRF), estimulando la producción y liberación de la hormona del crecimiento endógeno. Los efectos secundarios comunes incluyen artralgia, reacciones en el sitio de inyección, dolor en las extremidades, edema periférico y mialgia.
Theratechnologies (NASDAQ: THTX)는 EGRIFTA SV®에 대한 보충 생물학적 라이센스 신청(sBLA)의 사전 승인 보충(PAS)에 대해 FDA 승인을 받았습니다. 이 승인으로 EGRIFTA SV®의 무제한 배포가 가능해지며, 이전의 재량에 따른 제품 출시 요구 사항이 제거됩니다.
EGRIFTA SV®는 현재 HIV 및 지방이영양증이 있는 성인의 과도한 복부 지방을 줄이기 위해 FDA에서 승인한 유일한 치료제입니다. FDA는 또한 EGRIFTA SV®를 대체할 새로운 F8 제형인 EGRIFTA WR™를 최근에 승인했습니다. 이는 환자 편의성을 개선합니다.
이 약물은 성장 호르몬 방출 인자(GHRF) 유사체로 작용하여 내인성 성장 호르몬의 생산과 방출을 자극합니다. 일반적인 부작용으로는 관절통, 주사 부위 반응, 사지 통증, 말초 부종 및 근육통이 포함됩니다.
Theratechnologies (NASDAQ: THTX) a reçu l'approbation de la FDA pour son supplément d'approbation préalable (PAS) à la demande de licence biologique complémentaire (sBLA) pour EGRIFTA SV®. Cette approbation permet la distribution sans restriction d'EGRIFTA SV®, supprimant les exigences de libération discrétionnaire du produit précédentes.
EGRIFTA SV® est actuellement le seul traitement approuvé par la FDA pour réduire l'excès de graisse abdominale chez les adultes vivant avec le VIH et la lipodystrophie. La FDA a également récemment approuvé une nouvelle formulation F8, EGRIFTA WR™, qui remplacera EGRIFTA SV® et offre une meilleure commodité pour les patients.
Le médicament agit comme un analogue du facteur de libération de l'hormone de croissance (GHRF), stimulant la production et la libération de l'hormone de croissance endogène. Les effets secondaires courants incluent l'arthralgie, les réactions au site d'injection, la douleur dans les extrémités, l'œdème périphérique et la myalgie.
Theratechnologies (NASDAQ: THTX) hat die FDA-Zulassung für sein Vorabgenehmigungs-Supplement (PAS) für den Antrag auf ergänzende biologische Lizenz (sBLA) für EGRIFTA SV® erhalten. Diese Genehmigung ermöglicht die uneingeschränkte Verteilung von EGRIFTA SV®, wodurch frühere diskretionäre Anforderungen für die Produktfreigabe entfallen.
EGRIFTA SV® ist derzeit die einzige von der FDA zugelassene Behandlung zur Reduzierung von überschüssigem Bauchfett bei Erwachsenen mit HIV und Lipodystrophie. Die FDA hat kürzlich auch eine neue F8-Formulierung, EGRIFTA WR™, genehmigt, die EGRIFTA SV® ersetzen wird und eine verbesserte Benutzerfreundlichkeit für die Patienten bietet.
Das Medikament wirkt als Analogon des Wachstumsfaktor freisetzenden Hormons (GHRF) und stimuliert die Produktion und Freisetzung von endogenem Wachstumshormon. Häufige Nebenwirkungen sind Arthralgie, Reaktionen an der Injektionsstelle, Schmerzen in den Extremitäten, periphere Ödeme und Myalgie.
- FDA approval enables unrestricted distribution of EGRIFTA SV
- New EGRIFTA WR formulation approved, offering improved patient convenience
- Maintains monopoly position as only FDA-approved treatment for HIV-related lipodystrophy
- Long-term cardiovascular safety not established
- therapeutic scope with weight-neutral effect
- Multiple contraindications and adverse reactions reported
Insights
The FDA's approval of Theratechnologies' Prior Approval Supplement (PAS) for EGRIFTA SV® represents a significant regulatory milestone that resolves a critical distribution limitation. This approval effectively removes discretionary product release requirements that had created supply uncertainty for the company's flagship product - the only FDA-approved treatment for reducing excess abdominal fat in HIV patients with lipodystrophy.
The timing is particularly strategic as it coincides with the recent FDA approval of EGRIFTA WR™, a new formulation designed to replace EGRIFTA SV®. The regulatory clearance creates a seamless transition pathway between formulations, allowing Theratechnologies to gradually migrate patients to the improved product while maintaining uninterrupted treatment access.
From a regulatory perspective, this dual approval scenario effectively:
- Eliminates immediate supply chain constraints for the existing product
- Clears the pathway for the launch of an improved formulation
- Removes uncertainty regarding manufactured batches
- Reestablishes normal distribution channels
This development secures Theratechnologies' market position in a specialized therapeutic area where they face competition. The company can now focus on commercializing their more convenient formulation rather than managing supply disruptions, potentially strengthening their revenue streams from this core product.
FDA action allows for unrestricted distribution of EGRIFTA SV®, removing uncertainty with respect to all manufactured batches
PAS approval follows recent FDA approval of new formulation, EGRIFTA WR™
MONTREAL, April 08, 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 Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV® (tesamorelin for injection). Tesamorelin for injection is the only treatment approved in the U.S. to reduce excess abdominal fat in adults with HIV and lipodystrophy.
Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing Theratechnologies to resume regular distribution of EGRIFTA SV®. The FDA also recently approved the new F8 formulation of tesamorelin for injection, which is set to replace EGRIFTA SV® and will be marketed in the US as EGRIFTA WR™.
“Securing FDA approval of the Prior Approval Supplement for the EGRIFTA SV® sBLA closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions,” said Paul Lévesque, President and CEO of Theratechnologies. “Now that we have also obtained approval of EGRIFTA WR™, we look forward to transitioning patients to this more convenient formulation, which we have designed to improve the patient experience.”
Important Safety Information for EGRIFTA SV®/ EGRIFTA WR™ (tesamorelin for injection)
Tesamorelin for injection is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy*. Tesamorelin for injection 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 tesamorelin for injection has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
- Tesamorelin for injection 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 tesamorelin for injection.
Contraindications:
Do not use tesamorelin for injection 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 tesamorelin for injection.
- Is pregnant or planning to become pregnant.
The most commonly reported adverse reactions of tesamorelin for injection 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 www.egriftasv.com for the full prescribing information, patient information and instructions for use. 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 replacement of EGRIFTA SV® with EGRIFTA WR™; and (ii) the distribution of EGRIFTA SV® without restrictions. 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 Company’s manufacturer of EGRIFTA SV® will be able to meet market demand and supply such product on a timely basis; (ii) EGRIFTA WR™, when commercially available, will be accepted by the marketplace; and (iii) EGRIFTA WR™ 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) EGRIFTA WR™ not being accepted by the marketplace; (ii) the manufacturer of EGRIFTA WR™ not being able to meet market demand for the product on a timely basis; (iii) EGRIFTA WR™ not being reimbursed by public and private payors; and (iv) untoward side effects related to the use of EGRIFTA WR™. 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:
Investor inquiries:
Joanne Choi
Senior Director, Investor Relations
jchoi@theratech.com
1-551-261-0401
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
FAQ
What is the significance of FDA's PAS approval for THTX's EGRIFTA SV?
How does THTX's EGRIFTA SV treat HIV-related lipodystrophy?
What are the key differences between EGRIFTA WR and EGRIFTA SV?
What are the main limitations of THTX's EGRIFTA treatment?
