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FDA Issues Partial Hold on DBV Viaskin Peanut Patch Trial
Another delay for the long-awaited therapy.
DBV Begins Phase 3 Study of Redesigned Viaskin Peanut Patch in Children Ages 4-7
Viaskin is testing a new version of their patch designed to address the FDA's concerns.
DBV Announces Positive Topline Results from Phase 3 Trial of Viaskin Peanut in Peanut-Allergic...
Viaskin Peanut demonstrated a statistically significant treatment effect with 67.0% of subjects meeting the treatment responder criteria after 12 months.
Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase 3 Trial
The patch therapy remains in regulatory limbo.
Safety of Viaskin Peanut Patch Therapy Improved Over 3-Year Study
Reactions decreased over study duration.
FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays
Delays mount pushing trials of modified patch.
DBV Optimistic Viaskin Peanut “Patch” Therapy has Path to Approval After FDA Feedback
DBV, which also has Viaskin therapies for milk and egg allergies in their pipeline, is encouraged by FDA feedback after denial of their peanut therapy.
Viaskin Peanut “Patch” Therapy Takes Next Step Toward Approval… in Europe
The Marketing Authorization Application for Viaskin™ Peanut was validated by the European Medicines Agency.
FDA Denies Approval of Viaskin Peanut “Patch” Therapy
The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.
Will the Viaskin “Patch” Therapy for Peanut Allergy be Approved Soon? The Company is...
Company is restructuring in anticipation of delays.
