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Pharmaceuticals / Inspections and Audits

Advisory Committee Supports Aimmune’s Peanut Allergy Drug

Sept. 23, 2019

An FDA advisory committee voted in favor of the risk-benefit profile of Aimmune Therapeutics’ peanut allergy therapy Palforzia (AR101). 

The Allergenic Products Advisory Committee voted 8-1 in favor of the oral immunotherapy’s safety and 7-2 for its efficacy for reducing the frequency and severity of allergic reactions in patients ages 4-17 exposed to peanut. The FDA granted the drug breakthrough therapy designation in 2015 and is currently reviewing a BLA.

Aimmune presented the results of a phase 3 clinical trial of 555 patients ages 4-55 with a peanut allergy, which showed that 67 percent of patients treated with the therapy could tolerate up to 600 milligrams of peanut protein with no more than mild to moderate symptoms.

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