Tag: Viaskin® Peanut

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.
OIT

Leading Allergists, Researchers and Food Allergy Advocates to Discuss State of...

The summit intends to address the risks and benefits of OIT, OIT implementation in practice and the gaps in knowledge about OIT to enable physicians to have a better understanding of this therapy and to help patients make fully-informed choices about treatment options.
Viaskin Peanut

DBV to Resubmit Application to FDA for Viaskin Peanut Approval in...

Company allays concerns that BLA would not be resubmitted.
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.
DBV Patch Closeup

Positive Safety Results Reported for Viaskin Peanut Phase III Trial

The trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events.

Viaskin Peanut Phase III Trial Falls Short, Still Chance for FDA...

The Viaskin Peanut patch therapy still has 50:50 chance of approval according to research note.