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A Food and Drug Administration panel on Friday recommended approval of the first-ever drug to treat life-threatening peanut allergies in children, a condition that confounds and frightens families across the country. The recommendation all but assures the agency will approve the drug, called Palforzia and made by Aimmune Therapeutics. The F.D.A. typically follows the advice of its expert advisory committees. (Rabin, 9/13)

The company is seeking approval for administering the drug to children ages 4 to 17. “For a family with high anxiety and a significant burden of anxiety and fear from living with [a] peanut allergy, this might give that extra buffer of safety,” said Marcus Shaker, a pediatric allergist at Dartmouth’s Geisel School of Medicine, who was not involved with the trial. “They’re still going to need to strictly avoid peanuts, but [this will help] to let go of some of the fear they may have.” (Johnson, 9/13)

The treatment is daily capsules of peanut powder that gradually help children build up a tolerance. The outside panel of advisers to the Food and Drug Administration voted overwhelmingly in favor of the treatment from Aimmune Therapeutics. The nonbinding vote amounts to an endorsement for approval. The FDA is expected to make its final decision by January. (9/13)

By an 8-1 margin, the experts agreed that the the FDA should require 1) Documentation that any patient prescribed Palforzia has a valid prescription for injectable epinephrine; 2) caregivers/patients must attest to carrying injectable epinephrine while on Palforzia; and 3 ) initial dose escalation and the first dose of each up-dosing level must be administered in a certified facility capable of treating systemic allergic reactions. (Feuerstein, 9/13)

The recommendation came despite concerns raised in some testimony that the treatment could actually lead to more allergic reactions, in some cases. "I also want my patients to have a lower risk of having reactions, but I think from the data that we have had presented to us that neither the safety nor efficacy have been demonstrated," said Dr. John Kelso, an allergy specialist at Scripps Clinic in San Diego. (Smith, 9/13)

Peanut allergies are the leading cause of death from food-induced allergic reactions in the United States but a lack of approved preventive treatments has left patients and caregivers desperate for options. Palforzia, previously known as AR101, is an oral immunotherapy consisting of fixed doses of powdered peanut that is sprinkled over food daily. (Mathias and Joseph, 9/13)

Research in recent years has raised hopes for a preventive treatment. Studies have shown that gradually introducing small amounts of foods containing peanuts to children could prevent or limit the severity of allergic reactions. That approach is known as oral immunotherapy. The drug developed by Aimmune, of Brisbane, Calif., builds on that concept. A study released last year found that the treatment helped reduce the incidence and severity of allergic reactions when children ingested a small amount of peanuts, compared with a placebo. (Loftus, 9/13)

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. (Kounang and Almasy, 9/13)