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Viaskin Peanut, an epicutaneous immunotherapy, delivers baby amounts of peanut protein through a wearable patch

The Biologics License Application (BLA) for Viaskin Peanut (DBV Technologies) has been submitted to the Food and Drug Administration (FDA) for the analysis of peanut abhorrence in accouchement 4-11 years old.

Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers baby amounts of peanut protein through a wearable application to abet desensitization. The BLA included abstracts from two Phase 3 trials, PEPITES and REALISE, as able-bodied as abiding abstracts from an open-label Phase 2 program.

In the PEPITES study, the assurance and ability of Viaskin Peanut 250µg peanut protein to abet desensitization to peanut in peanut-allergic accouchement 4 through 11 years of age afterwards a 12-month analysis was evaluated. Results showed that 35.3% of abstraction patients had a statistically cogent acknowledgment vs 13.6% of patients in the placebo arm. For patients with a baseline peanut protein eliciting dosage (ED) ≤10mg, a responder was authentic as a accommodating with a peanut protein ED ≥300mg of peanut protein afterwards 12 months of treatment. For patients with a baseline ED >10mg, a responder was authentic as a accommodating with a peanut protein ED ≥1000mg of peanut protein afterwards 12 months of treatment.

Data from the REALISE abstraction added approved a favorable assurance and tolerability profile. “We accept that the assurance and ability abstracts generated in our analytic trials abutment our mission to potentially action EPIT, a proprietary desensitization treatment, to peanut-allergic accouchement in an accessible and acceptable address for families,” said Dr Hugh Sampson, Chief Scientific Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai.

Understanding The Background Of Fda Allergen Labeling | Fda Allergen Labeling – fda allergen labeling
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Petition · Add Sesame Seeds as an allergen to US Product labeling ..
Petition · Add Sesame Seeds as an allergen to US Product labeling .. | fda allergen labeling

 

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