Tag: Epicutaneous Immunotherapy (EPIT)

Viaskin Patch

DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut...

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
ICER Final Report

ICER’s Final Report on Peanut Allergy Treatments: Clinical Evidence Does Not...

The report evaluates Viaskin® Peanut and AR101, as well as non-commercialized oral immunotherapy (OIT).
AAFA Press Release Regarding ICER Review

Asthma and Allergy Foundation of America Elevates Patient Voice in ICER...

Affirms Burden of Food Allergies on Families, Patients, and Caregivers.
FARE-ACAAI-AAN Statement

Joint Statement on Peanut Allergy Therapy Review

Organizations representing patients and allergists urge ICER to adopt a more patient-driven approach to assessing immunotherapies for peanut allergy.
Giorgi Sisters

Must See: ‘ViewFinder: Food for Thought – Food Allergies’

This documentary should be required viewing for everyone as the food allergy epidemic has affected so many in the community.
Viaskin Peanut

DBV Withdraws FDA Application for Viaskin Peanut with Plan to Resubmit

The company believes the additional information needed to support this filing is available without further clinical studies.
Peanuts

Non-Profit Institute to Review Benefits of Commercial, Private Practice Immunotherapies for...

An independent review of the value, costs and effectiveness of Viaskin Peanut, AR101, and private practice peanut OIT.
Viaskin Peanut

DBV Applies for FDA License to Sell Viaskin Peanut Patch Therapy

"This submission represents a significant step forward for those families living with peanut allergy."
Viaskin Patch

Viaskin Peanut Completes Phase III Part A Study of Toddlers With...

Part B expected to commence in 2018Q4 with Viaskin Peanut 250 µg.
OIT

Study: Immunotherapy Trials for Food Allergy Hold Strong Appeal for Parents

Child’s food allergies have major impact on parents’ lives; majority of parents are willing to enroll their child in an immunotherapy clinical trial

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