First Drug for Peanut Allergy Nears FDA Approval

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The Food and Drug Administration has voted in favor of a new treatment for children with peanut allergies. Final approval decisions will occur by January, 2020.

Raquel Perry, Reporter/Marketing Manager

On Friday, September 13, the US Food and Drug Administration’s Allergenic Products Advisory Committee voted in favor of a new treatment option for children with peanut allergies.

The new treatment, called Palforzia, is a daily pill that aims to slowly build up tolerance to peanuts for children ages 4-17. The pill was produced by Aimmune Therapeutics, inc. It is an oral immunotherapy, which increases the amount of allergen each dose, with the goal of increasing the intensity that is required to trigger the reaction.

According to the American College of Allergy, Asthma, and Immunology, more than 3 million Americans are allergic to peanuts and tree nuts. More than 2.5% of American children are allergic to peanuts, as it is one of the most common food allergies in the United States. Symptoms include cramping, indigestion, diarrhea, shortness of breath, tightness of breath, hives, and swelling.

“We are very pleased that the FDA Allergenic Products Advisory Committee has voted in support of Palforzia,” stated Jayson Dallas, CEO of Aimmune Therapeutics. “This recommendation recognizes the urgent need for patients to have a treatment option for their potentially life-threatening allergy.”

The drug would not allow those with peanut allergies to eat nuts, peanut butter, or other products freely, but would protect them in the event of accidental exposure.

In their study, participants experienced serious side effects, but 67 percent were able eat two to three peanuts with no allergic reaction.

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 allergies.