Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment
Theratechnologies (TSX: TH, NASDAQ: THTX) has submitted a Prior Approval Supplement (PAS) to the FDA regarding changes in the manufacturing environment for EGRIFTA SV®. The FDA's review process typically takes four months, and approval is required before distributing recently manufactured batches. Current inventory is expected to last until mid-January 2025. The company is in discussions with FDA divisions to expedite the release of EGRIFTA SV® to prevent potential patient-level shortages. The product is exclusively distributed in the United States.
Theratechnologies (TSX: TH, NASDAQ: THTX) ha presentato un Supplemento di Approvazione Preliminare (PAS) alla FDA riguardante modifiche nell'ambiente di produzione per EGRIFTA SV®. Il processo di revisione della FDA richiede normalmente quattro mesi, e l'approvazione è necessaria prima della distribuzione dei lotti recentemente prodotti. Si prevede che l'inventario attuale duri fino a metà gennaio 2025. L'azienda è in discussione con le divisioni della FDA per accelerare il rilascio di EGRIFTA SV® al fine di prevenire potenziali carenze a livello di pazienti. Il prodotto è distribuito esclusivamente negli Stati Uniti.
Theratechnologies (TSX: TH, NASDAQ: THTX) ha presentado un Suplemento de Aprobación Previas (PAS) a la FDA sobre cambios en el entorno de fabricación de EGRIFTA SV®. El proceso de revisión de la FDA suele tomar cuatro meses, y es necesaria la aprobación antes de distribuir los lotes recientemente fabricados. Se espera que el inventario actual dure hasta mediados de enero de 2025. La empresa está en conversaciones con divisiones de la FDA para acelerar la liberación de EGRIFTA SV® y evitar posibles escasez a nivel de pacientes. El producto se distribuye exclusivamente en los Estados Unidos.
Theratechnologies (TSX: TH, NASDAQ: THTX)는 EGRIFTA SV®의 제조 환경 변경에 대한 사전 승인 보완(PAS)을 FDA에 제출했습니다. FDA의 검토 프로세스는 일반적으로 4개월이 소요되며, 최근 생산된 배치를 유통하기 위해서는 승인이 필요합니다. 현재 재고는 2025년 1월 중순까지 유지될 것으로 예상됩니다. 회사는 환자 수준의 잠재적 부족을 방지하기 위해 EGRIFTA SV®의 출시를 가속화하기 위해 FDA 부서와 논의하고 있습니다. 이 제품은 미국에서만 독점적으로 유통됩니다.
Theratechnologies (TSX: TH, NASDAQ: THTX) a soumis un supplément de demande d'approbation préalable (PAS) à la FDA concernant des modifications de l'environnement de fabrication pour EGRIFTA SV®. Le processus de révision de la FDA prend généralement quatre mois, et une approbation est nécessaire avant la distribution des nouveaux lots fabriqués. On s'attend à ce que l'inventaire actuel dure jusqu'à mi-janvier 2025. L'entreprise est en discussion avec les divisions de la FDA pour accélérer la mise sur le marché de l'EGRIFTA SV® afin d'éviter d'éventuelles pénuries au niveau des patients. Le produit est distribué exclusivement aux États-Unis.
Theratechnologies (TSX: TH, NASDAQ: THTX) hat einen Antrag auf Vorabgenehmigung (PAS) bei der FDA eingereicht, der sich auf Änderungen der Produktionsumgebung für EGRIFTA SV® bezieht. Der Überprüfungsprozess der FDA dauert in der Regel vier Monate, und die Genehmigung ist erforderlich, bevor neu hergestellte Chargen verteilt werden. Es wird erwartet, dass der aktuelle Bestand bis mitte Januar 2025 ausreicht. Das Unternehmen steht in Gesprächen mit den Abteilungen der FDA, um die Freigabe von EGRIFTA SV® zu beschleunigen und potenzielle Engpässe auf Patientenebene zu vermeiden. Das Produkt wird ausschließlich in den Vereinigten Staaten vertrieben.
- None.
- Risk of EGRIFTA SV® supply shortage by mid-January 2025
- Four-month FDA review period could impact product availability
- Manufacturing changes requiring FDA approval causing potential distribution delays
Insights
The PAS submission for EGRIFTA SV® manufacturing environment changes represents a critical regulatory milestone with significant supply chain implications. The standard 4-month FDA review timeline poses a substantial risk, as current inventory is projected to last only until mid-January 2025. This timing mismatch creates a potential 1-3 month supply gap that could directly impact revenue and patient care.
The manufacturing environment modifications, while necessary, create a complex regulatory scenario. The FDA's accelerated review discussions are crucial, but historical precedent suggests expedited approvals are rare for manufacturing changes. The company's proactive engagement with multiple FDA divisions indicates awareness of the urgency but doesn't guarantee a faster timeline.
For context, EGRIFTA SV® generated
The inventory situation presents a concerning timeline with significant operational risks. With inventory coverage only until mid-January 2025 and a standard FDA review period of 4 months from December 2024, there's a high probability of a supply chain disruption. This creates a critical business continuity challenge, particularly as EGRIFTA SV® is exclusively distributed in the U.S. market.
The gap between current inventory depletion and potential regulatory approval could trigger several downstream effects:
- Potential loss of patients to alternative treatments
- Increased costs from emergency supply chain management
- Revenue impact from missed sales during any shortage period
MONTREAL, Dec. 18, 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 that the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility where EGRIFTA SV® is produced. A PAS is reviewed by the FDA within four months of receipt and an approval is needed prior to the distribution of the recently manufactured batches of EGRIFTA SV®.
Existing inventory levels of EGRIFTA SV® are expected to meet patient demand until mid-January 2025. Theratechnologies therefore continues discussions with the relevant FDA divisions in an effort to accelerate the release of EGRIFTA SV® and avoid a product shortage at the patient level.
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 the review period of the PAS by the FDA, the availability of EGRIFTA SV® to patients and the avoidance of an EGRIFTA SV® shortage at the patient level. 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 PAS as filed will meet FDA’s regulatory requirements; (ii) the classification of the Company’s third party manufacturing site as official action indicated (OAI) will not result in the issuance of a complete response letter (CRL) following the submission of the PAS; (iii) the Company will be successful in its discussions with the various FDA divisions leading to the release of the recently manufactured batches of EGRIFTA SV® in order to avoid a drug shortage at the patient level; (iv) the FDA will review and approve the PAS before mid-January 2025; and (v) market demand for EGRIFTA SV® will remain unaffected despite the risk, or the occurrence, of a drug shortage. 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 occurrence of a drug shortage of EGRIFTA SV® due to various factors, including the inability of the Company to convince the FDA to accelerate the review timelines of the PAS or agree to alternative solutions allowing the release of the recently manufactured batches of EGRIFTA SV®, the rejection of the PAS for failure to meet regulatory requirements, the issuance of comments by the FDA on the PAS impacting its review timelines, the issuance of a CRL requiring the Company’s manufacturing site to be reinspected prior to any newly-manufactured batch of EGRIFTA SV® being released to the market; (ii) reduced revenues in the Company’s first quarter of its fiscal year 2025 in the event the PAS is not reviewed expeditiously or alternative solutions are not implemented allowing the Company to resume sales of EGRIFTA SV® before a four-month period; and (iii) patient attrition and lower demand for EGRIFTA SV® as a result of a drug shortage. 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:
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 EGRIFTA SV® inventory run out according to Theratechnologies (THTX)?
How long will the FDA take to review Theratechnologies' Prior Approval Supplement for EGRIFTA SV®?
What is the purpose of Theratechnologies' (THTX) Prior Approval Supplement filing?
Where is EGRIFTA SV® currently distributed by Theratechnologies (THTX)?
