DBV Technologies today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that delivers biologically active compounds to the immune system
Kids With Food Allergies is sharing this press release from DBV Technologies to bring you the latest research news quickly. [PRESS RELEASE] DBV Technologies Provides Update on Regulatory Status of Viaskin Peanut for the Treatment of PeanutAllergic Children 4 to 11 Years of Age Progress made to date to enable BLA resubmission in Q3 2019 Company to hold conference call today, February 13th, at 4:30 ET / 22:30 CET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market:...
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin® Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts.
The Food and Drug Administration agreed to review a skin patch for peanut allergy on an expedited basis following positive results of recent clinical trials, the company said Thursday. DBV Technologies said that the FDA granted its Viaskin...
DBV Technologies today announced that after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn. DBV is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible.
DBV Technologies, a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.
Press Release: Consortium of Food Allergy Research Completes Recruitment of NIH-sponsored CoFar6 Phase II Trial with DBV's Viaskin(r) Peanut in Treatment of Peanut Allergy Leading US centers in food allergy involved in an NIH-funded CoFAR6 study,...
DBV Technologies, a clinical-stage biopharmaceutical company, today announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin® Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure.
This is great news! I have a 17-year old with a peanut allergy, but I see this was tested only on younger kids. Will this be potentially tested/available for older kids/adults as well? Also, any thoughts/ideas at all on when this will be through testing and approval and available for the general peanut-allergic population?
Hi, Carolyn ... there is a lot of exciting research into immunotherapy right now. For instance, the FDA is now considering the immunotherapy drug Palforzia for children and teens with peanut allergy. And research has been ongoing with drugs like Viaskin. I have much hope that families managing food allergies will have many additional tools in their kit in the future. In the meantime, how can our community help you and your teen?
Thanks for the response. I Googled Palforzia and a link came up to a recent article in the Atlantic (9/13/09) stating this "drug" is nothing but peanut flour in a capsule, with an estimated cost of $4200/year!...and the need for the patient to take it indefinitely. Even if it reliably worked (not proven per the article), it just also seems like another way for the pharmaceutical industry to rip off families of allergic kids (Epi-pen exorbitant costs, case in point).
It makes me so happy to read about positive results on treating people with a peanut allergy. My grandson is 10 now...and I am sometimes gripped with fear regarding his allergy. I am so hoping that a real cure is on the horizon...for him and for all of those dealing with this. Thanks for all you do to keep us informed.
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company’s Biologics License Application (BLA) for investigational Viaskin™ Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
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