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.
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.