Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review
Theratechnologies has resubmitted its supplemental Biologics License Application (sBLA) to the FDA for the F8 formulation of tesamorelin, addressing concerns raised in January 2024's Complete Response Letter. The F8 formulation aims to replace EGRIFTA SV® with simplified dosing for treating excess abdominal fat in HIV patients with lipodystrophy. The FDA's previous concerns focused on chemistry, manufacturing and controls, and immunogenicity risk information. The FDA will review the updated application within four months, with a decision expected around March 2025. The new formulation is patent protected until 2033.
Theratechnologies ha ripresentato la sua domanda supplementare di licenza biologica (sBLA) alla FDA per la formulazione F8 di tesamorelin, affrontando le preoccupazioni sollevate nella lettera di risposta completa di gennaio 2024. La formulazione F8 mira a sostituire EGRIFTA SV® con un dosaggio semplificato per il trattamento dell'eccesso di grasso addominale nei pazienti HIV con lipodistrofia. Le preoccupazioni precedenti della FDA si sono concentrate su chimica, produzione e controlli, e informazioni sul rischio di immunogenicità. La FDA esaminerà la domanda aggiornata entro quattro mesi, con una decisione prevista per marzo 2025. La nuova formulazione è protetta da brevetto fino al 2033.
Theratechnologies ha presentado nuevamente su solicitud suplementaria de licencia biológica (sBLA) a la FDA para la formulación F8 de tesamorelin, abordando las preocupaciones planteadas en la carta de respuesta completa de enero de 2024. La formulación F8 tiene como objetivo reemplazar EGRIFTA SV® con una dosificación simplificada para tratar el exceso de grasa abdominal en pacientes con VIH que padecen lipodistrofia. Las inquietudes previas de la FDA se centraron en la química, la manufactura y los controles, así como en la información sobre el riesgo de inmunogenicidad. La FDA revisará la solicitud actualizada en un plazo de cuatro meses, con una decisión esperada alrededor de marzo de 2025. La nueva formulación está protegida por patente hasta 2033.
Theratechnologies는 tesamorelin의 F8 제형에 대한 보충 생물학적 허가 신청(sBLA)을 FDA에 재제출했으며, 이는 2024년 1월의 완전 응답서에서 제기된 우려를 해결하기 위한 것입니다. F8 제형은 HIV 환자의 지방 분포 이상으로 인한 복부 비만을 치료하기 위해 EGRIFTA SV®를 간소화된 용법으로 대체하는 것을 목표로 하고 있습니다. FDA의 이전 우려는 화학, 제조 및 품질 관리, 면역원성 위험 정보에 집중되었습니다. FDA는 업데이트된 신청서를 4개월 내에 검토할 예정이며, 결정은 2025년 3월경에 예상됩니다. 새로운 제형은 2033년까지 특허 보호를 받고 있습니다.
Theratechnologies a soumis à nouveau sa demande de licence biologique complémentaire (sBLA) à la FDA pour la formulation F8 de tesamorelin, répondant aux préoccupations soulevées dans la lettre de réponse complète de janvier 2024. La formulation F8 vise à remplacer EGRIFTA SV® par une posologie simplifiée pour traiter l'excès de graisse abdominale chez les patients VIH atteints de lipodystrophie. Les préoccupations précédentes de la FDA concernaient la chimie, la fabrication et les contrôles, ainsi que les informations sur le risque d'immunogénicité. La FDA examinera la demande mise à jour dans un délai de quatre mois, une décision étant attendue autour de mars 2025. La nouvelle formulation est protégée par un brevet jusqu'en 2033.
Theratechnologies hat seinen ergänzenden biologischen Zulassungsantrag (sBLA) erneut bei der FDA für die F8-Formulierung von Tesamorelin eingereicht, um die Bedenken aus dem vollständigen Antwortschreiben von Januar 2024 zu adressieren. Die F8-Formulierung zielt darauf ab, EGRIFTA SV® durch eine vereinfachte Dosierung zur Behandlung von überschüssigem Bauchfett bei HIV-Patienten mit Lipodystrophie zu ersetzen. Die vorherigen Bedenken der FDA konzentrierten sich auf Chemie, Herstellung und Kontrollen sowie Informationen zum Risiko der Immunogenität. Die FDA wird den aktualisierten Antrag innerhalb von vier Monaten prüfen, eine Entscheidung wird für März 2025 erwartet. Die neue Formulierung ist bis 2033 durch Patente geschützt.
- Patent protection for F8 formulation extends until 2033
- Simplified dosing regimen could improve patient compliance
- FDA review timeline is relatively short at 4 months
- Previous FDA rejection in January 2024 required resubmission
- Regulatory uncertainty remains until FDA approval
Insights
This sBLA resubmission for tesamorelin F8 formulation represents a significant regulatory milestone for Theratechnologies. The F8 formulation aims to improve upon EGRIFTA SV by offering simplified dosing - a key factor for patient compliance in HIV-related lipodystrophy treatment. The FDA's request for clarification on CMC and immunogenicity risk suggests thorough scrutiny of manufacturing processes and safety profile.
The March 2025 expected decision timeline and patent protection until 2033 provide a clear regulatory and IP runway. However, investors should note that while addressing the January 2024 CRL is positive progress, FDA approval isn't guaranteed. The company's market position as the only approved treatment for HIV-related excess abdominal fat makes this regulatory milestone particularly important for maintaining their therapeutic niche.
Resubmission addresses questions raised in January 2024 Complete Response Letter
F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy
MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced the resubmission of its supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the F8 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Theratechnologies has filed the resubmission to address concerns raised in the FDA’s Complete Response Letter (CRL) to the initial F8 formulation sBLA filing. In the CRL, which was issued in January 2024, the FDA requested clarifications largely related to chemistry, manufacturing and controls (CMC), as well as further information on immunogenicity risk.
“We are confident in our sBLA resubmission after discussing our response approach with the FDA in a Type A meeting,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “The F8 formulation of tesamorelin would simplify dosing for people with HIV who face the clinical challenges of excess abdominal fat. We look forward to further collaboration with the FDA as the agency reviews our updated application.”
The FDA will review the updated sBLA within four months of submission. Theratechnologies therefore expects a decision around the end of March 2025. The new formulation is patent protected in the U.S. until 2033.
About EGRIFTA SV® (tesamorelin for injection)
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.
Refer to www.egriftasv.com for the full prescribing information, patient information and instructions for use for further details about this product.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. 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 (formerly Twitter).
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 time period related to the review of the sBLA by the FDA; and (ii) the benefits to patients associated with the use of the F8 formulation, if approved. 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 FDA will complete its review within the timelines set forth in the press release; (ii) the Company’s responses to the issues raised by the FDA in its CRL will be satisfactory to the FDA; (iii) the FDA will approve the sBLA for the F8 formulation; and (iv) if approved, health care providers and patients will adopt the F8 formulation.
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) the review period of the sBLA which could be longer than the timelines set forth in this press release, ; (ii) the non-approval of the sBLA by the FDA, or the issuance of another CRL; and (iii) the negative reception by the marketplace of the F8 formulation, if approved. 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 21, 2024 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:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
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