Medexus Provides Update on Treosulfan NDA Review Process and Extended PDUFA Goal Date
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) announced that the FDA has extended the review period for the New Drug Application (NDA) for treosulfan by three months. The new PDUFA target action date is set for January 30, 2025. This extension is due to the FDA requiring additional time to review supplemental analyses of previously submitted data, which they determined constitutes a major amendment.
The treosulfan NDA seeks approval for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients with acute myeloid leukemia and myelodysplastic syndromes. Despite the delay, Medexus remains optimistic and continues to prepare for a potential approval and commercial launch in the first half of 2025.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) ha annunciato che la FDA ha prolungato il periodo di revisione per la Nuova Richiesta di Farmaco (NDA) relativa a treosulfan di tre mesi. La nuova data target per l'azione PDUFA è fissata per 30 gennaio 2025. Questo prolungamento è dovuto alla necessità della FDA di avere ulteriore tempo per rivedere le analisi supplementari dei dati precedentemente inviati, che sono stati considerati una modifica significativa.
La NDA per treosulfan mira ad ottenere l'approvazione per l'uso in combinazione con fludarabina come regime preparatorio per il trapianto di cellule staminali ematopoietiche allogeniche in pazienti adulti e pediatrici con leucemia mieloide acuta e sindromi mielodisplastiche. Nonostante il ritardo, Medexus rimane ottimista e continua a prepararsi per una possibile approvazione e lancio commerciale nel primo semestre del 2025.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) anunció que la FDA ha extendido el período de revisión para la Nueva Solicitud de Medicamento (NDA) para treosulfán por tres meses. La nueva fecha objetivo de acción PDUFA está establecida para el 30 de enero de 2025. Esta extensión se debe a que la FDA requiere tiempo adicional para revisar análisis suplementarios de datos previamente presentados, que han sido considerados una modificación importante.
La NDA de treosulfán busca la aprobación para su uso en combinación con fludarabina como régimen preparatorio para el trasplante de células madre hematopoyéticas alogénicas en pacientes adultos y pediátricos con leucemia mieloide aguda y síndromes mielodisplásicos. A pesar de la demora, Medexus se mantiene optimista y continúa preparándose para una posible aprobación y lanzamiento comercial en la primera mitad de 2025.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF)가 FDA가 신약 신청(NDA)에 대한 검토 기간을 3개월 연장했다고 발표했습니다. 새로운 PDUFA 목표 조치 날짜는 2025년 1월 30일로 설정되었습니다. 이번 연장은 FDA가 이전에 제출된 데이터에 대한 보충 분석을 추가적으로 검토하기 위한 시간이 필요하다고 판단했기 때문입니다. 이는 주요 수정 사항으로 간주됩니다.
treosulfan NDA는 플루다라빈과의 병용 사용에 대한 승인을 목표로 하며, 이는 성인 및 소아 환자의 급성 골수성 백혈병 및 골수이형성 증후군에 대한 조혈모세포 이식 준비 요법으로 사용됩니다. 지연에도 불구하고, Medexus는 낙관적이며 2025년 상반기에 잠재적인 승인 및 상업적 출시를 준비하고 있습니다.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) a annoncé que la FDA a prolongé la période d'examen de la Demande de Nouveau Médicament (NDA) pour treosulfan de trois mois. La nouvelle date cible d'action PDUFA est fixée au 30 janvier 2025. Ce prolongement est dû au fait que la FDA a besoin de temps supplémentaire pour examiner les analyses supplémentaires des données précédemment soumises, considérées comme une modification majeure.
La NDA pour treosulfan vise à obtenir l'approbation pour une utilisation en combinaison avec fludarabine comme régime préparatoire pour la transplantation de cellules souches hématopoïétiques allogènes chez des patients adultes et pédiatriques atteints de leucémie myéloïde aiguë et de syndromes myélodysplasiques. Malgré le retard, Medexus reste optimiste et continue de se préparer à une approbation potentielle et à un lancement commercial dans la première moitié de 2025.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) gab bekannt, dass die FDA den Überprüfungszeitraum für den Antrag auf Neuzulassung (NDA) für Treosulfan um drei Monate verlängert hat. Das neue Ziel-Datum für die PDUFA Maßnahme ist auf 30. Januar 2025 festgelegt. Diese Verlängerung ist darauf zurückzuführen, dass die FDA zusätzliche Zeit benötigt, um ergänzende Analysen der zuvor eingereichten Daten zu überprüfen, die als wesentliche Änderung eingestuft wurden.
Der NDA für Treosulfan zielt darauf ab, die Genehmigung für die Anwendung in Kombination mit Fludarabin als Vorbereitungsregime für allogene Blutstammzelltransplantation bei erwachsenen und pädiatrischen Patienten mit akuter myeloischer Leukämie und myelodysplastischen Syndromen zu erhalten. Trotz der Verzögerung bleibt Medexus optimistisch und bereitet sich weiterhin auf eine mögliche Genehmigung und Markteinführung im ersten Halbjahr 2025 vor.
- FDA remains actively engaged in the review process
- Medexus continues preparations for potential approval and launch in H1 2025
- No new clinical data requested by FDA
- FDA extends NDA review period by 3 months
- New PDUFA date set for January 30, 2025, delaying potential market entry
- Additional time required for FDA to review supplemental analyses
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - September 16, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has been informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has extended the review period for the New Drug Application for treosulfan by three months. The FDA has set a new PDUFA target action date of January 30, 2025.
The FDA notified medac that the Agency requires additional time to review supplemental analyses of previously submitted data that had been provided by medac in response to the FDA's routine information requests, having determined that the additional information constitutes a major amendment, which allows the FDA up to three additional months to complete their review. The FDA has not requested submission of new clinical data.
"We recognize that this development further extends the regulatory review process timeline," commented Ken d'Entremont, Medexus's Chief Executive Officer. "Nevertheless, we are encouraged to see that the FDA remains actively engaged with medac, and we continue to prepare for an approval of treosulfan in the United States and a commercial launch in the first half of calendar year 2025."
The treosulfan NDA seeks approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult and pediatric patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
About Medexus
Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of oncology, hematology, rheumatology, auto-immune diseases, allergy, and dermatology. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.
Contacts
Ken d'Entremont | CEO, Medexus Pharmaceuticals
Tel: 905-676-0003 | Email: ken.dentremont@medexus.com
Brendon Buschman | CFO, Medexus Pharmaceuticals
Tel: 416-577-6216 | Email: brendon.buschman@medexus.com
Victoria Rutherford | Adelaide Capital
Tel: 480-625-5772 | Email: victoria@adcap.ca
Forward-looking statements
Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, statements regarding: the potential benefits of treosulfan; the occurrence, timing, and expected outcome of the FDA review process for treosulfan; and, if approved by the FDA, and if the Company's ongoing negotiations with medac to further amend the US treosulfan agreement are successful, the expected timing of any commercial launch of the product in the relevant market and related expectations regarding the product's prospects, and the potential competitive position of the product and anticipated trends and potential challenges in the market in which the product is expected to compete. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Without limiting the generality of the foregoing, see "Risk Factors and Risk Management-Possible failure to realize benefits of the US Treosulfan Agreement" in Medexus's most recent MD&A, including in respect of the specified negotiation period currently underway. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/223363
FAQ
What is the new PDUFA date for Medexus Pharmaceuticals' (MEDXF) treosulfan NDA?
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