DBV Technologies is a global biopharmaceutical company that is pioneering investigational epicutaneous immunotherapy (EPIT) technology. Millions of people suffer from life-threatening food allergies and other immunological disorders. For more than 15 years, DBV Technologies has been striving to deliver transformative treatments for patients suffering with the burden and life-threatening risk of food allergies. Starting with peanut, DBV Technologies is investigating food allergy treatments that are designed to potentially reduce the risk of unpredictable, life-threatening reactions due to accidental exposure. Investigational Viaskin® Peanut therapeutic treatment is based on epicutaneous immunotherapy, or EPIT™ This potential new class of immunotherapy is designed to work by delivering allergens to the immune system through intact skin using our proprietary Viaskin technology. Information on the Viaskin Platform is located here.
Well-designed clinical trials are the cornerstone of how we develop medicines and are critical to the understanding of the safety and efficacy of new medicines. Clinical trial recruitment is essential to complete these pivotal trials required for approval of a drug by a regulatory authority, such as the U.S. Food and Drug Administration (FDA). Phase 3 clinical trials assessing the safety and efficacy of Viaskin® Peanut for the treatment of peanut-allergic patients are ongoing. At this time, DBV Technologies is recruiting and enrolling peanut allergic children ages 1-3 in an investigational clinical trial to determine the efficacy and safety of Viaskin® Peanut. The name of that trial is EPITOPE. More information regarding participation criteria and trial locations can be found online at https://clinicaltrials.gov/. Also, our website links to the specific trial information on clinicaltrials.gov. The REALISE (Real Life Use and Safety of EPIT) Phase 3 study in children 4 to 11 years of age, has completed recruitment (NCT 02916446). For children completing the REALISE or PEOPLE clinical trials, an expanded access program is available for the continued treatment with Viaskin® Peanut.
Requesting Expanded Access
All requests for Expanded Access after completion of the REALISE (V712-302) or PEOPLE (V712-303) clinical studies must be made by a treating physician on behalf of the child and the child's parent or adult guardian. DBV Technologies has opened an Expanded Access Program for Viaskin® Peanut post-trial treatment. A treating physician may submit questions or requests regarding Expanded Access by emailing firstname.lastname@example.org or by calling Early Access Care at 203-441-7939 and speaking with an Early Access Coordinator. Patients must provide informed consent for Expanded Access. No patient is guaranteed entry into the program solely by applying. Requests will be acknowledged within one business day.
Physicians must follow local laws and regulations appropriate for the country originating the request.
In the U.S. physicians may find additional information on Expanded Access by visiting the U.S. Food and Drug Administration website Expanded Access: Information for Physicians.
Physicians in Canada must follow regulations specific to Canada, by following the procedure found here for Special Access Request.
April 6, 2020