Theratechnologies Provides Update on EGRIFTA SV® Supply
Theratechnologies (TSX: TH) (NASDAQ: THTX) announced an upcoming shortage of EGRIFTA SV® (tesamorelin for injection) expected to affect patients by mid-January 2025. The shortage follows a voluntary shutdown of the contract manufacturing facility in 2024, with several pharmacies already reporting stockouts despite remaining inventory in certain U.S. locations.
The company filed a Prior Approval Supplement to the FDA on December 18, 2024, and submitted additional questions through a Type D meeting request regarding two recently manufactured batches awaiting release. The FDA has committed to responding in writing by February 8, 2025. EGRIFTA SV®, exclusively distributed in the United States, is the only FDA-approved medicine of its kind for people with HIV.
Theratechnologies (TSX: TH) (NASDAQ: THTX) ha annunciato una prossima carenza di EGRIFTA SV® (tesamorelin per iniezione) prevista per colpire i pazienti entro metà gennaio 2025. La carenza segue un'interruzione volontaria dello stabilimento di produzione su contratto nel 2024, con diverse farmacie che già segnalano esaurimenti di scorte nonostante sia presente inventario in alcune località degli Stati Uniti.
L'azienda ha presentato un supplemento per l'approvazione preventiva alla FDA il 18 dicembre 2024, e ha inviato ulteriori domande tramite una richiesta di incontro di tipo D riguardo a due lotti recentemente prodotti in attesa di rilascio. La FDA si è impegnata a rispondere per iscritto entro l'8 febbraio 2025. EGRIFTA SV®, distribuito esclusivamente negli Stati Uniti, è l'unico farmaco approvato dalla FDA della sua categoria per le persone con HIV.
Theratechnologies (TSX: TH) (NASDAQ: THTX) anunció una próxima escasez de EGRIFTA SV® (tesamorelina para inyección) que se espera afecte a los pacientes a mediados de enero de 2025. La escasez sigue a un cierre voluntario de la planta de fabricación por contrato en 2024, con varias farmacias ya reportando desabastecimientos a pesar de tener inventario en ciertas localidades de EE. UU.
La compañía presentó un suplemento de aprobación previa a la FDA el 18 de diciembre de 2024 y envió preguntas adicionales a través de una solicitud de reunión de tipo D sobre dos lotes recientemente fabricados que esperan liberación. La FDA se comprometió a responder por escrito antes del 8 de febrero de 2025. EGRIFTA SV®, distribuido exclusivamente en Estados Unidos, es el único medicamento de su tipo aprobado por la FDA para personas con VIH.
Theratechnologies (TSX: TH) (NASDAQ: THTX)는 EGRIFTA SV® (주사용 테사모렐린)의 부족이 2025년 1월 중순까지 환자에게 영향을 미칠 것이라고 발표했습니다. 이 부족 사태는 2024년 계약 제조 시설의 자발적인 폐쇄에 따른 것으로, 여러 약국에서 특정 미국 지역에서 재고가 있음에도 불구하고 이미 재고 부족을 보고하고 있습니다.
회사는 2024년 12월 18일 FDA에 사전 승인 보충서를 제출했으며, 출시를 기다리고 있는 최근 제조된 두 배치에 대한 질문을 제기하기 위해 유형 D 회의 요청을 통해 추가 질문을 제출했습니다. FDA는 2025년 2월 8일까지 서면으로 답변할 의사를 밝혔습니다. EGRIFTA SV®는 미국에서 독점적으로 유통되며, HIV 환자를 위한 유일한 FDA 승인 약물입니다.
Theratechnologies (TSX: TH) (NASDAQ: THTX) a annoncé une prochaine pénurie de EGRIFTA SV® (tésamorelina pour injection) qui devrait affecter les patients d'ici la mi-janvier 2025. La pénurie fait suite à une fermeture volontaire de l'établissement de fabrication sous contrat en 2024, plusieurs pharmacies signalant déjà des ruptures de stock bien qu'il reste des inventaires dans certaines localités des États-Unis.
L'entreprise a déposé un supplément de demande préalable auprès de la FDA le 18 décembre 2024 et a soumis des questions supplémentaires par le biais d'une demande de réunion de type D concernant deux lots récemment fabriqués en attente de libération. La FDA s'est engagée à répondre par écrit d'ici le 8 février 2025. EGRIFTA SV®, distribué exclusivement aux États-Unis, est le seul médicament de ce type approuvé par la FDA pour les personnes vivant avec le VIH.
Theratechnologies (TSX: TH) (NASDAQ: THTX) hat einen bevorstehenden Mangel an EGRIFTA SV® (Tesamorelin zur Injektion) angekündigt, der voraussichtlich im Januar 2025 Patienten betreffen wird. Der Mangel folgt auf eine freiwillige Schließung der Vertragsfertigungsanlage im Jahr 2024, wobei mehrere Apotheken bereits von Engpässen berichten, obwohl noch Bestände an bestimmten Standorten in den USA vorhanden sind.
Das Unternehmen hat am 18. Dezember 2024 einen Antrag auf vorherige Genehmigung bei der FDA eingereicht und zusätzliche Fragen über eine Anfrage für ein Typ-D-Meeting zu zwei kürzlich hergestellten Chargen gestellt, die auf die Freigabe warten. Die FDA hat sich verpflichtet, bis zum 8. Februar 2025 schriftlich zu antworten. EGRIFTA SV®, das exklusiv in den Vereinigten Staaten vertrieben wird, ist das einzige von der FDA zugelassene Medikament seiner Art für Menschen mit HIV.
- Two new batches of EGRIFTA SV® have been manufactured and are awaiting release
- FDA has committed to a response by February 8, 2025
- EGRIFTA SV® maintains exclusive position as only FDA-approved medicine of its kind
- Patient-level shortage of EGRIFTA SV® expected by mid-January 2025
- Several pharmacies already reporting stockouts
- Manufacturing facility shutdown in 2024 affecting product supply
- Regulatory approval pending for new batches, creating uncertainty in supply chain
Insights
The voluntary shutdown of EGRIFTA SV®'s contract manufacturing facility in 2024 leading to mid-January 2025 stockouts represents a critical supply chain disruption for Theratechnologies' flagship product. With
The situation is particularly concerning as EGRIFTA SV® is the sole FDA-approved treatment of its kind for HIV patients, creating a monopolistic market position that typically would be advantageous but now represents a critical healthcare gap. Two manufactured batches await release approval, suggesting proactive production occurred, but regulatory hurdles are creating a bottleneck. The PAS filing on December 18, 2024, indicates potential manufacturing process changes that require thorough FDA review.
For investors, this represents elevated near-term risk due to potential revenue loss during the shortage period and possible market share erosion if patients are forced to seek alternative treatments. The distribution to only the U.S. market concentrates this risk geographically.
The regulatory timeline here is particularly noteworthy. The FDA's commitment to respond by February 8, 2025, to the Type D meeting request suggests this isn't being treated as an emergency review despite the looming shortage. The Prior Approval Supplement (PAS) filed in December typically indicates substantial manufacturing changes requiring comprehensive FDA review, which could extend beyond the February response date.
The combination of a voluntary manufacturing shutdown with subsequent PAS filing suggests possible GMP compliance issues or significant process modifications. The fact that two completed batches await release approval while shortages loom indicates regulatory complexities beyond routine quality control. This regulatory pathway chosen by Theratechnologies - PAS followed by Type D meeting questions - might prove longer than alternative emergency protocols, raising questions about the severity of underlying manufacturing issues.
MONTREAL, Jan. 09, 2025 (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 that a shortage of EGRIFTA SV® (tesamorelin for injection) will occur at the patient level in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024. While the Company is aware of remaining inventory of EGRIFTA SV® in certain pharmacies throughout the United States, several pharmacies have reported stockouts.
Theratechnologies filed a required Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) on December 18, 2024. The Company subsequently submitted questions as part of a Type D meeting request concerning the status of two recently manufactured batches of EGRIFTA SV®, which are waiting to be released to pharmacies. The FDA confirmed that it would respond to the Company’s questions in writing no later than February 8, 2025.
“We remain committed to people with HIV who rely on EGRIFTA SV®, as it is the only FDA-approved medicine of its kind, and we will continue to work with the FDA to expedite the release of the new batches for patients,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.
The Company will update the market on any further material developments.
EGRIFTA SV® is distributed in the United States only.
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 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 availability of EGRIFTA SV® to patients; (ii) the date by which the FDA will respond to the Company’s questions following its request to have a Type D meeting; and (iii) the timelines related to the potential release of the recently manufactured batches of 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 FDA will provide answers to the questions asked by the Company by February 8, 2025; (ii) the responses to the questions asked by the Company will confirm that the Company is able to release the recently manufactured batches of EGRIFTA SV® or will confirm that the review of the PAS will be completed prior to the expiry of a four-month period; (iii) current market demand for EGRIFTA SV® will remain unaffected; (iv) the shortage of EGRIFTA SV® will not adversely impact the financial conditions of the Company; and (v) the Company will be able to negotiate waivers of defaults with its secured creditors to the extent the drug shortage period results in defaults under its credit agreements. 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) delays in responding to the Company’s questions beyond February 8, 2025; (ii) refusal by the FDA to release the recently manufactured batches of EGRIFTA SV® until the PAS review is completed; (iii) FDA’s review of the PAS not being completed before April 18, 2025; (iv) non-approval of the PAS; (v) issuance of questions as part of the PAS review by the FDA resulting in delays in completing the PAS review and resulting in delays beyond April 18, 2025 to release the recently manufactured batches of EGRIFTA SV®; (vi) issuance of a complete response letter following the filing of the PAS as a result of the manufacturing site being classified as Official Action Indicated preventing the Company from releasing the recently manufactured batches of EGRIFTA SV®; (vii) a decrease in demand for EGRIFTA SV® due to its shortage potentially adversely impacting the resumption of the commercialization of EGRIFTA SV®; (viii) losses of key employees due to the shortage; and (ix) defaults under the covenants of the credit agreements resulting from the shortage. The Company refers current and potential investors to the “Risk Factors” section of the Company’s 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:
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
When will the EGRIFTA SV® shortage begin for Theratechnologies (THTX) patients?
What caused the 2025 EGRIFTA SV® supply shortage for Theratechnologies (THTX)?
When did Theratechnologies (THTX) file the Prior Approval Supplement for EGRIFTA SV®?
When will the FDA respond to Theratechnologies' (THTX) Type D meeting request for EGRIFTA SV®?
How many new batches of EGRIFTA SV® does Theratechnologies (THTX) have awaiting release?
