FDA News

FDA grants breakthrough designation for Viaskin Peanut in children

The FDA granted breakthrough therapy designation to Viaskin Peanut, an epicutaneous delivery system, for the treatment of children aged 6 to 11 years with peanut allergy, according to a manufacturer’s press release.

The Viaskin Peanut (DBV Technologies) system, which delivers a precise quantity of the allergen to the skin, is intended to circumvent contact between the allergen and the bloodstream, conferring a greater level of safety as systemic reactions can be avoided.

“We are truly honored to be the first company to receive this FDA designation in food allergies. This is a historical event for peanut allergy patients, caretakers and clinicians who have long awaited a treatment for this severe disease,” Pierre-Henri Benhamou, MD, chairman and CEO of DBV Technologies, said in a press release. “In addition to the fast track designation already granted in December 2011, this breakthrough designation highlights the urgent need to find a treatment for this life-threatening disease, and we are committed to bringing Viaskin Peanut to the market as quickly as possible.”

The FDA based its decision on efficacy and safety results from the phase 2b Viaskin Peanut Efficacy and Safety trial (VIPES), which demonstrated that Viaskin Peanut 250 mcg improved peanut allergy disease in children.

In the trial, Viaskin Peanut was applied at three dose levels (50 mcg, 100 mcg, 250 mcg peanut protein) vs. placebo for 12 months in patients aged 6 to 55 years in two age cohorts (children aged 6 to 11 years, n = 113; adolescents and adults, n =108).

The trial met its primary efficacy endpoint at the highest dose (Viaskin Peanut 250 mcg), which exhibited a higher proportion of responding patients (50%) vs. placebo (25%) after 12 months of epicutaneous immunotherapy (P = .0108).

The FDA granted breakthrough therapy designation to Viaskin Peanut, an epicutaneous delivery system, for the treatment of children aged 6 to 11 years with peanut allergy, according to a manufacturer’s press release.

The Viaskin Peanut (DBV Technologies) system, which delivers a precise quantity of the allergen to the skin, is intended to circumvent contact between the allergen and the bloodstream, conferring a greater level of safety as systemic reactions can be avoided.

“We are truly honored to be the first company to receive this FDA designation in food allergies. This is a historical event for peanut allergy patients, caretakers and clinicians who have long awaited a treatment for this severe disease,” Pierre-Henri Benhamou, MD, chairman and CEO of DBV Technologies, said in a press release. “In addition to the fast track designation already granted in December 2011, this breakthrough designation highlights the urgent need to find a treatment for this life-threatening disease, and we are committed to bringing Viaskin Peanut to the market as quickly as possible.”

The FDA based its decision on efficacy and safety results from the phase 2b Viaskin Peanut Efficacy and Safety trial (VIPES), which demonstrated that Viaskin Peanut 250 mcg improved peanut allergy disease in children.

In the trial, Viaskin Peanut was applied at three dose levels (50 mcg, 100 mcg, 250 mcg peanut protein) vs. placebo for 12 months in patients aged 6 to 55 years in two age cohorts (children aged 6 to 11 years, n = 113; adolescents and adults, n =108).

The trial met its primary efficacy endpoint at the highest dose (Viaskin Peanut 250 mcg), which exhibited a higher proportion of responding patients (50%) vs. placebo (25%) after 12 months of epicutaneous immunotherapy (P = .0108).