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FDA Approves First Drug for Peanut Allergy

By Jim Crumly - Feb 3, 2020 at 6:05PM

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The first approved drug for any food allergy may be the first of several from Aimmune Therapeutics.

The U.S. Food and Drug Administration (FDA) approved the first treatment for peanut allergies late Friday, and shares of the company that developed it, Aimmune Therapeutics (AIMT) rose 6.4% today on the news. Palforzia is the first FDA-approved therapy for any food allergy and becomes Aimmune's first commercial product.

Palforzia is an immunotherapy designed to desensitize patients to potentially life-threatening allergic reactions to peanuts and is approved for use with patients aged 4 through 17. Children with a severe peanut allergy are at risk of accidental exposure to trace amounts of peanuts in the environment or in foods that may not even have peanuts as a listed ingredient, potentially resulting in anaphylaxis.

Boy holding up hand to bowl of peanuts.

Image source: Getty Images.

The treatment, a complex biologic drug that's derived from peanuts themselves, won't allow patients to eat peanuts freely but results from a clinical trial last year showed that 58% of patients treated with Palforzia tolerated peanut protein equivalent to three or four peanuts, compared with 2.3% in the placebo group. Aimmune has priced the drug at $890 per month, with a co-pay program to help bring down the out-of-pocket cost.

Aimmune says the milestone is just the beginning. The specialist in food allergies is awaiting approval for Palforzia in Europe and is conducting a trial for the drug in children between 1 and 4 years old. It also has products in its pipeline for egg and tree nut allergies.

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