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FDA issues first approval for peanut allergy drug treatment

by FDA

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On Jan. 31, the U.S. Food and Drug Administration (FDA) approved Palforzia, produced by Aimmune Therapeutics, to lessen allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.

Palforzia is an oral immunotherapy shown to help some children and teens increase tolerance, reducing the likelihood of a serious reaction from accidental exposure to peanuts. It uses increasing doses of peanut flour to help a body deal with the ingestion of protein powder without a serious systemic reaction.

Peanut allergy is a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful, triggering an allergic reaction. According to the FDA, peanut allergy affects 1 million children in the U.S., and only 20% of them outgrow the allergy. The FDA indicated that treatment may be administered in people ages 4 to 17 with a confirmed diagnosis of peanut allergy. Palforzia is not a cure, and people who take it must continue to avoid peanuts in their diets. Palforzia cannot be used as an emergency treatment of allergic reactions.

Palforzia is a powder that is manufactured from peanuts. Treatment using Palforzia is a series of escalating doses until the maintenance dosage is reached. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food - such as applesauce, yogurt, or pudding - that the patient then consumes.

For more information, see the FDA press release.

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