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Tagged With "Viaskin"

Blog Post

DBV Submits Viaskin Peanut Treatment for FDA Biologics License

KFA News Team ·
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
Blog Post

DBV to Resubmit Viaskin Peanut Treatment for FDA Biologics License

KFA News Team ·
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:...
Blog Post

FDA Accepts Application for Viaskin Peanut Patch for Review

KFA News Team ·
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.
Blog Post

FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

Kids With Food Allergies ·
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...
Blog Post

FDA Application for Peanut Patch for Children 4 to 11 Years of Age Is Withdrawn

KFA News Team ·
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its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn.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.
Blog Post

DBV Resubmits Viaskin Peanut Allergy Treatment to FDA

KFA News Team ·
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.
Blog Post

Food Allergy Research Update: Viaskin Study for Peanut Allergy

KFA News Team ·
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,...
Blog Post

Peanut Patch Shows Positive Results During Clinical Trial

KFA News Team ·
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.
Comment

Re: Peanut Patch Shows Positive Results During Clinical Trial

JenniferW. ·
GOD bless those participants.
Comment

Re: Peanut Patch Shows Positive Results During Clinical Trial

K8sMom2002 ·
Welcome, JenniferW! Yes, research helps everyone, and we so appreciate the families who give their time and effort to helping with research! What allergies does your family manage? How can we help?
Comment

Re: Peanut Patch Shows Positive Results During Clinical Trial

Carolyn25 ·
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?
Comment

Re: Peanut Patch Shows Positive Results During Clinical Trial

K8sMom2002 ·
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?
Comment

Re: Peanut Patch Shows Positive Results During Clinical Trial

Carolyn25 ·
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).
Comment

Re: Peanut Patch Shows Positive Results During Clinical Trial

Jen07 ·
I have an 18 year old with a peanut allergy and I too am very interested to learn about what might be available to him in the future. Any information is very welcomed. Thank you!!
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Re: Peanut Patch Shows Positive Results During Clinical Trial

Grammy123 ·
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.
Comment

Re: FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

Abigail's Mommy ·
How can we find a Phase III trial? I'm interested in doing this.
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Re: FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

StephC ·
Same here. And how do we get notified about trials for milk?
Comment

Re: DBV to Resubmit Viaskin Peanut Treatment for FDA Biologics License

Nutfreemama1 ·
Waiting for this! Already tried oit and slit.
Blog Post

Viaskin™ Peanut Patch Not Approved in Its Present Form - DBV to Request Meeting With FDA

KFA News Team ·
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.
Comment

Re: Viaskin™ Peanut Patch Not Approved in Its Present Form - DBV to Request Meeting With FDA

Juneau ·
We have been looking forward to this patch for years and my kid may be too old by the time it gets approved. So much safer than other peanut allergy treatments.
Kids With Food Allergies
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