FDA takes major step toward approving first peanut allergy treatment
(CNN) — The US Food and Drug Administration’s Allergenic Products Advisory Committee on Friday voted in favor of approving a treatment for peanut allergies in children.
The drug Palforzia is designed to minimize the incidence and severity of allergic reactions in people from ages 4 to 17 with peanut allergies.
The American College of Allergy, Asthma and Immunology says that more than 2.5% of American children are allergic to peanuts.
Peanut allergy is one of the most common food allergies in US children. If children who are allergic to peanuts are exposed to them, they may experience an array of symptoms including cramping, indigestion, diarrhea, shortness of breath, tightness of breath, hives and swelling.
The most severe reaction is anaphylaxis, when the entire body responds with symptoms including impaired breathing, a sudden drop in blood pressure, and fainting and dizziness. If not treated immediately, anaphylaxis can be fatal.
Current advice for people with allergies is to avoid peanuts. If exposed, people with allergies should use a drug like injectable epinephrine, commonly sold as EpiPen, or for milder reactions, antihistamines.
Palforzia works essentially by exposing children to controlled dosages of peanut protein until they’ve reached a maintenance level. The company says in documents filed ahead of Friday’s meeting with the advisory committee that the treatment is a powder mixed once each day with certain foods like apple sauce, yogurt and pudding..
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. However, about 9% of children dosed with Palforzia during the trial had to stop the treatment because their allergic reactions were so severe.
While the advisory committee has voted in favor of the treatment, the FDA will make its final approval by January. If approved, this will become the first FDA approved treatment for peanut allergy
