Date: 2015-04-09
Type of information: Granting of the Breakthrough Therapy status
Product name: Viaskin® Peanut
Compound:
Therapeutic area: Allergic diseases - Immunological diseases
Action mechanism: The Viaskin® technology platform, which delivers biologically active compounds, including allergens, via intact skin. Viaskin® is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.
Company: DBV Technologies (France)
Disease: peanut allergy in children
Latest news: * On April 9, 2015, DBV Technologies, a clinical stage specialty biopharmaceutical company, announced that the FDA has granted Breakthrough Therapy Designation to Viaskin® Peanut for children.Currently, DBV is actively preparing the launch of its Phase III trial of Viaskin Peanut in Children, suffering from peanut allergy, in close coordination with the US FDA.
The FDA granted this Breakthrough Therapy Designation after DBV reported positive Phase IIb results with Viaskin Peanut. The Viaskin® Peanut Efficacy and Safety trial, or VIPES, is a Phase IIb study demonstrating that Viaskin Peanut 250 μg improved the peanut allergy disease in children, as measured by a clinically significant endpoint. Available safety data from past and ongoing studieswith Viaskin Peanut demonstrate an excellent safety profile in all age groups.
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Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
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Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
