MediWound Announces U.S. Food and Drug Administration Approval of NexoBrid® for the Treatment of Pediatric Patients with Severe Thermal Burns
MediWound (Nasdaq: MDWD) has announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for use in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. This approval expands NexoBrid's use to all age groups in the U.S., aligning with its approvals in the European Union and Japan.
The approval was supported by the results of the global Phase III Children Innovation Debridement Study (CIDS), funded by BARDA, as well as additional pediatric data from Phase III and Phase II studies. This milestone is significant as pediatric burn victims represent over 30% of the total burn population, and NexoBrid offers a non-surgical alternative to the current traumatic standard of care.
MediWound (Nasdaq: MDWD) ha annunciato che la Food and Drug Administration (FDA) degli Stati Uniti ha approvato NexoBrid® (anacaulase-bcdb) per l'uso in pazienti pediatrici dai neonati ai diciotto anni con ustioni termiche profonde parziali e/o totali. Questa approvazione estende l'uso di NexoBrid a tutte le fasce d'età negli Stati Uniti, in linea con le sue approvazioni nell'Unione Europea e in Giappone.
L'approvazione è stata supportata dai risultati del Children Innovation Debridement Study (CIDS) di fase III a livello globale, finanziato da BARDA, insieme a ulteriori dati pediatrici provenienti da studi di fase III e II. Questa pietra miliare è significativa poiché le vittime pediatriche di ustioni rappresentano oltre il 30% della popolazione totale di ustionati, e NexoBrid offre un'alternativa non chirurgica allo standard attuale di cura traumatica.
MediWound (Nasdaq: MDWD) ha anunciado que la Administración de Alimentos y Medicamentos de EE. UU. (FDA) ha aprobado NexoBrid® (anacaulase-bcdb) para su uso en pacientes pediátricos desde recién nacidos hasta dieciocho años con quemaduras térmicas de grosor parcial profundo y/o total. Esta aprobación amplía el uso de NexoBrid a todos los grupos de edad en EE. UU., alineándose con sus aprobaciones en la Unión Europea y Japón.
La aprobación fue respaldada por los resultados del Children Innovation Debridement Study (CIDS) de fase III a nivel global, financiado por BARDA, así como datos pediátricos adicionales de estudios de fase III y II. Este hito es significativo ya que las víctimas pediátricas de quemaduras representan más del 30% de la población total de quemados, y NexoBrid ofrece una alternativa no quirúrgica al estándar actual de atención traumática.
MediWound (Nasdaq: MDWD)는 미국 식품의약국(FDA)가 NexoBrid® (anacaulase-bcdb)를 모든 연령대의 소아 환자 (신생아부터 18세까지)에게 깊은 부분 및/또는 전층 화상 치료에 사용할 수 있도록 승인했다고 발표했습니다. 이 승인은 NexoBrid의 사용을 미국 내 모든 연령대로 확대하며, 이는 유럽연합 및 일본에서의 승인과 일치합니다.
이 승인은 BARDA의 자금 지원을 받은 글로벌 제3상 Children Innovation Debridement Study (CIDS)의 결과와 제3상 및 제2상 연구의 추가 소아 데이터를 기반으로 지원되었습니다. 이 이정표는 소아 화상 피해자가 전체 화상 인구의 30% 이상을 차지한다는 점에서 중요하며, NexoBrid는 현재의 외상 치료 표준에 대한 비수술적 대안을 제공합니다.
MediWound (Nasdaq: MDWD) a annoncé que la Food and Drug Administration (FDA) des États-Unis a approuvé NexoBrid® (anacaulase-bcdb) pour une utilisation chez les patients pédiatriques âgés de la naissance à dix-huit ans présentant des brûlures thermiques de profondeur partielle et/ou totale. Cette approbation élargit l'utilisation de NexoBrid à tous les groupes d'âge aux États-Unis, en accord avec ses approbations dans l'Union Européenne et au Japon.
L'approbation a été soutenue par les résultats de l'étude mondiale de phase III Children Innovation Debridement Study (CIDS), financée par la BARDA, ainsi que par des données pédiatriques supplémentaires provenant d'études de phase III et II. Ce jalon est significatif car les victimes pédiatriques des brûlures représentent plus de 30 % de la population totale des brûlés, et NexoBrid offre une alternative non chirurgicale à la norme actuelle des soins traumatiques.
MediWound (Nasdaq: MDWD) hat angekündigt, dass die U.S. Food and Drug Administration (FDA) NexoBrid® (anacaulase-bcdb) zur Anwendung bei pädriatrischen Patienten von Neugeborenen bis zu achtzehn Jahren mit tiefen Teil- und/oder Vollbrandverletzungen genehmigt hat. Diese Genehmigung erweitert die Anwendung von NexoBrid auf alle Altersgruppen in den USA, was mit seinen Genehmigungen in der Europäischen Union und Japan übereinstimmt.
Die Genehmigung wurde durch die Ergebnisse der globalen Phase-III-Studie Children Innovation Debridement Study (CIDS), finanziert von BARDA, sowie durch zusätzliche pädiatrische Daten aus Phase-III- und Phase-II-Studien unterstützt. Dieser Meilenstein ist bedeutend, da pädiatrische Brandopfer über 30% der gesamten Brandopferpopulation ausmachen, und NexoBrid bietet eine nicht-chirurgische Alternative zum derzeitigen traumatischen Standard der Versorgung.
- FDA approval for pediatric use of NexoBrid, expanding market reach
- NexoBrid now approved for all age groups in the U.S., EU, and Japan
- Addresses 30% of burn population (pediatric patients)
- Offers non-surgical alternative to current traumatic standard of care
- None.
Insights
The FDA's approval of NexoBrid for pediatric burn patients is a significant advancement in burn care. This enzymatic debriding agent offers a non-surgical alternative for eschar removal, potentially reducing trauma and complications associated with traditional surgical debridement. The approval, based on the CIDS trial and additional studies, demonstrates robust efficacy and safety data in children from newborns to 18 years old.
This expansion to include all age groups aligns NexoBrid's U.S. approval with its status in the EU and Japan, potentially streamlining treatment protocols globally. The backing by BARDA underscores the product's strategic importance in burn care and emergency preparedness. For MediWound, this approval could significantly expand NexoBrid's market reach, given that pediatric burns account for over
The FDA approval for NexoBrid's pediatric indication is a major catalyst for MediWound (NASDAQ: MDWD). This expansion could substantially increase the addressable market for NexoBrid, potentially boosting revenue streams. With pediatric burns representing over
Investors should note that this approval strengthens MediWound's market position and could lead to increased adoption in burn centers. The alignment with EU and Japan approvals may also facilitate global marketing efforts. However, the financial impact will depend on factors such as pricing strategy, reimbursement policies and market penetration rates. Shareholders should monitor upcoming quarterly reports for indications of NexoBrid's sales growth and its contribution to MediWound's overall financial performance.
Approval Helps Solidify NexoBrid’s Position in the U.S. as a Safe and Effective Non-Surgical Burn Treatment for All Ages
YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. for all age groups, aligning with its approvals in the European Union and Japan.
“Today's announcement marks a significant milestone in our mission to improve burn care with NexoBrid,” said Ofer Gonen, Chief Executive Officer of MediWound. “Pediatric burn victims represent over
The submission was supported by the results of a global Phase III clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase III and Phase II studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.
About NexoBrid®
NexoBrid® is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid® is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories.
NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of rapid and effective biologics that improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including the company’s lead drug under development, EscharEx®. EscharEx® is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant
For more information visit www.mediwound.com and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
| MediWound Contacts: Hani Luxenburg Chief Financial Officer MediWound Ltd. ir@mediwound.com | Daniel Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com |
| Media Contact: Ellie Hanson FINN Partners for MediWound ellie.hanson@finnpartners.com +1-929-588-2008 |
FAQ
What is the new FDA approval for MediWound's NexoBrid (MDWD)?
What age groups is NexoBrid (MDWD) now approved for in the U.S.?
What clinical study supported the pediatric approval of NexoBrid (MDWD)?
What percentage of burn victims are pediatric patients, according to MediWound (MDWD)?
