The U.S. Food and Drug Administration has given a “breakthrough therapy” designation to the new Viaskin Peanut product.
The epicutaneous delivery system for peanut allergy treatment is targeted towards children aged 6 to 11 years. The new “breakthrough” designation is given by the FDA to fast-track approval for market.
“We are truly honored to be the first company to receive this FDA designation in food allergies,” Pierre-Henri Benhamou, MD, chairman and CEO of DBV Technologies, said in a press release. “This is a historical event for peanut allergy patients, caretakers and clinicians who have long awaited a treatment for this severe disease.”
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The designation from the FDA and fast-track towards approval for market for the Viaskin Peanut product were given after a successful human trial. Applied at three dosage levels against a placebo over a year’s time, patients aged 6 to 55 years of age were compared with the children and adolescents in the group having the greatest benefit. By the end of the trial, about 50 percent of patients had very little immuno-response to raw peanuts compared to their response at the beginning of the trial.
The FDA based its decision on efficacy and safety results from that phase 2b Viaskin Peanut Efficacy and Safety trial (VIPES), which demonstrated that Viaskin Peanut 250 mcg improved peanut allergy reactions in children.