DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
DBV Technologies has secured FDA alignment on an Accelerated Approval pathway for the Viaskin® Peanut patch in toddlers aged 1-3 years. The FDA confirmed that efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for approval. The company plans to initiate the COMFORT Toddlers study in Q2 2025, enrolling approximately 480 subjects across multiple countries.
The COMFORT Toddlers study will be a six-month double-blind, placebo-controlled trial followed by an optional 18-month open-label treatment phase. DBV anticipates submitting a Biologics License Application (BLA) for the toddler indication in the second half of 2026. The FDA has also agreed on criteria for a post-marketing confirmatory study, which will need to be initiated at the time of BLA submission.
DBV Technologies ha ottenuto l'allineamento della FDA su un percorso di approvazione accelerata per il cerotto Viaskin® Peanut per i bambini di età compresa tra 1 e 3 anni. La FDA ha confermato che i dati di efficacia dello studio EPITOPE di Fase 3 possono essere utilizzati come un endpoint clinico intermedio per l'approvazione. L'azienda prevede di avviare lo studio COMFORT Toddlers nel secondo trimestre del 2025, reclutando circa 480 soggetti in diversi paesi.
Il progetto dello studio COMFORT Toddlers sarà un trial controllato, in doppio cieco e con placebo della durata di sei mesi, seguito da una fase di trattamento aperto opzionale di 18 mesi. DBV prevede di presentare una domanda di licenza per prodotti biologici (BLA) per l'indicazione pediatrica nella seconda metà del 2026. La FDA ha inoltre concordato i criteri per uno studio confermativo post-marketing, che dovrà essere avviato al momento della presentazione della BLA.
DBV Technologies ha asegurado la alineación de la FDA en un camino de aprobación acelerada para el parche Viaskin® Peanut en niños de 1 a 3 años. La FDA confirmó que los datos de eficacia del estudio EPITOPE de Fase 3 pueden servir como un endpoint clínico intermedio para la aprobación. La compañía planea iniciar el estudio COMFORT Toddlers en el segundo trimestre de 2025, inscribiendo aproximadamente 480 sujetos en varios países.
El estudio COMFORT Toddlers será un ensayo controlado, doble ciego y con placebo de seis meses, seguido de una fase de tratamiento abierto opcional de 18 meses. DBV anticipa presentar una Solicitud de Licencia de Biológicos (BLA) para la indicación pediátrica en la segunda mitad de 2026. La FDA también ha acordado los criterios para un estudio confirmatorio post-comercialización, que deberá iniciarse en el momento de la presentación de la BLA.
DBV Technologies는 1세에서 3세 아동을 위한 Viaskin® Peanut 패치의 가속 승인 경로에 대해 FDA의 합의를 확보했습니다. FDA는 3상 EPITOPE 연구의 효능 데이터가 승인을 위한 중간 임상 기준점으로 사용될 수 있음을 확인했습니다. 이 회사는 2025년 2분기에 약 480명의 피험자를 여러 국가에서 모집하여 COMFORT Toddlers 연구를 시작할 계획입니다.
COMFORT Toddlers 연구는 6개월간의 이중맹검, 위약 대조 시험으로 진행되며, 그 후 선택적인 18개월 오픈 라벨 치료 단계가 이어집니다. DBV는 2026년 하반기에 아동 적응증에 대한 생물학적 제품 면허 신청서(BLA)를 제출할 계획입니다. FDA는 또한 BLA 제출 시 시작해야 하는 사후 마케팅 확인 연구를 위한 기준에 합의하였습니다.
DBV Technologies a obtenu l'alignement de la FDA sur un chemin d'approbation accélérée pour le patch Viaskin® Peanut destiné aux enfants de 1 à 3 ans. La FDA a confirmé que les données d'efficacité de l'étude EPITOPE de phase 3 peuvent servir de critère clinique intermédiaire pour l'approbation. La société prévoit d'initier l'étude COMFORT Toddlers au deuxième trimestre de 2025, recrutant environ 480 sujets dans plusieurs pays.
L'étude COMFORT Toddlers sera un essai contrôlé en double aveugle et placebo de six mois, suivi d'une phase de traitement ouverte de 18 mois en option. DBV prévoit de soumettre une demande de licence biologique (BLA) pour l'indication pédiatrique au second semestre de 2026. La FDA a également convenu des critères pour une étude de confirmation post-commercialisation, qui devra être lancée au moment de la soumission de la BLA.
DBV Technologies hat die Zustimmung der FDA zu einem beschleunigten Genehmigungsweg für das Viaskin® Peanut-Pflaster für Kleinkinder im Alter von 1 bis 3 Jahren erhalten. Die FDA bestätigte, dass die Wirksamkeitsdaten der Phase-3-EPITOPE-Studie als intermediärer klinischer Endpunkt für die Genehmigung dienen können. Das Unternehmen plant, die COMFORT Toddlers-Studie im zweiten Quartal 2025 zu starten und etwa 480 Probanden in mehreren Ländern zu rekrutieren.
Die COMFORT Toddlers-Studie wird eine sechsmonatige, doppelblinde, placebo-kontrollierte Studie sein, gefolgt von einer optionalen 18-monatigen offenen Behandlungsphase. DBV plant, in der zweiten Hälfte des Jahres 2026 einen Antrag auf biologische Lizenz (BLA) für die Kleinkinderindikation einzureichen. Die FDA hat auch die Kriterien für eine nach dem Markt bestätigende Studie vereinbart, die zum Zeitpunkt der BLA-Einreichung gestartet werden muss.
- FDA confirmation of Accelerated Approval pathway reduces regulatory risk
- Phase 3 EPITOPE study data accepted as intermediate clinical endpoint
- Clear regulatory timeline established with BLA submission planned for 2H 2026
- Agreement reached on post-marketing study requirements
- Manufacturing changes require additional validation through COMFORT study
- BLA submission timeline pushed to 2H 2026
- Need for post-marketing confirmatory study adds development costs
Insights
Châtillon, France, December 11th, 2024
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
- DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis
- COMFORT Toddlers study on-track to initiate in 2Q 2025
- Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026
- FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old
- Company to host investor webcast today at 5:00pm ET
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study.
“DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22nd press release announcing details in support of our separate Viaskin Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in Europe,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible.”
Accelerated Approval Pathway
The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria:
- That the product candidate treats a serious condition
- That the product candidate generally provides a meaningful advantage over available therapies
- That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit
As DBV previously announced, FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two.
FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company’s Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval.
In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient’s skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location.
Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study.
Post-Marketing Confirmatory Study
In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted.
To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial.
The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the
“When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). “I’m pleased to learn that DBV’s constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider.”
COMFORT Toddlers Supplemental Safety Study
COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study.
“I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study,” stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. “Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial.”
The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 – 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers.
As previously disclosed, DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA:
- FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint.
- Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety).
- The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data.
DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.
Biologic License Application Submission in 1 – 3 Year-Olds
There will be two Phase 3 studies in 1 – 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission:
- Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine in May 2023), and 36 months of open-label extension data.
- Six months of DBPC data generated in COMFORT Toddlers supplemental safety study.
DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026.
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, Wednesday, December 11th, at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
- United States: +1-877-346-6112
- International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.
Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin® Peanut patch and EPIT™, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, DBV’s expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.
Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies.
Investor Contact
Katie Matthews
DBV Technologies
katie.matthews@dbv-technologies.com
Media Contact
Angela Marcucci
DBV Technologies
angela.marcucci@dbv-technologies.com
Attachment
FAQ
When will DBV Technologies (DBVT) begin the COMFORT Toddlers study for Viaskin Peanut patch?
What is the expected timeline for DBVT's Viaskin Peanut patch BLA submission for toddlers?
How many subjects will be enrolled in DBVT's COMFORT Toddlers study?
What clinical endpoints did the FDA accept for DBVT's Viaskin Peanut patch accelerated approval?
How long will DBVT's COMFORT Toddlers study last?
