An FDA committee voted in favor of approving a treatment for peanut allergies in children. If the full FDA votes for it, it would be the first FDA-approved treatment for peanut allergy.
The drug Palforzia is designed to minimize the incidence and severity of allergic reactions in people from ages 4 to 17 with peanut allergies. While the advisory committee has voted in favor of the treatment, the FDA will make its final approval by January. The agency frequently follows the lead of the advisory committee. If approved, this will become the first FDA approved treatment for peanut allergy.
A phase 3 trial submitted as evidence in favor of the drug by the manufacturers found that 2/3 of children were able to eat the equivalent of 2 peanuts without any allergic symptoms after the course of treatment. Patients may be required to take the therapy for six months or longer. The company said the most common adverse effects were abdominal discomfort or pain, coughing, hives, itching, nausea, throat irritation and vomiting.
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