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news.French biopharmaceutical firm DBV Technologies has received positive opinion from the European Medicines Agency's (EMA) Paediatric Committee (PDCO) on its paediatric investigation plan (PIP) for Viaskin Peanut.
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With the acceptance of PIP, the company will be able to submit a marketing authorization application (MAA) in Europe following completion of the Viaskin Peanut phase III program.
The PIP provides a comprehensive clinical development plan for Viaskin Peanut in children from one to 17 years of age who are allergic to peanuts.
The positive opinion on the company’s PIP is based on phase IIb trial results.
The Viaskin Peanut Efficacy and Safety (VIPES) phase IIb trial showed that Viaskin Peanut 250µg improved the peanut allergy disease in children.
In the double-blind placebo-controlled safety and efficacy Phase IIb VIPES trial Viaskin Peanut was evaluated at three dose-levels versus placebo for 12 months in an adult and pediatric populations of 221 subjects aged 6-55 years in 2 age strata (113 children aged 6-11 years, 108 adolescents and adults).
DBV Technologies chairman and CEO Dr Pierre-Henri Benhamou said: "This PIP acceptance is the first regulatory milestone in Europe for Viaskin Peanut, and we are thrilled to see that our clinical program continues to move forward.
"We are now well positioned to focus on the launch of our Viaskin Peanut Phase III trial in children."
According to the company, available safety data from past and ongoing trials with Viaskin Peanut show a robust safety profile in children, adolescents and adults.