After 8 hours of contentious discussion, an advisory committee to the U.S. Food and Drug Administration (FDA) today endorsed the effectiveness of a first-of-its-kind peanut allergy treatment. By a seven-to-two vote, the panel concluded that the treatment, known as AR101, can reduce allergic reactions from accidental exposure to peanuts. The committee also voted eight to one to endorse a safety plan FDA has proposed; it would be used, along with available safety data, to support the treatment’s use in children and teenagers.
FDA is not bound to follow its advisory committees’ advice but often does. It will now weigh whether to approve the treatment, which is marketed by the company Aimmune Therapeutics headquartered in Brisbane, California.
The vote marks a turning point for the food allergy field, where the treatment—ingesting gradually increasing doses of peanut protein, in hopes of helping the immune system learn to tolerate it—has captured the attention of patients, families, and doctors. Called oral immunotherapy, it’s already offered by about 200 allergists in the United States who give patients calibrated doses of peanut products in the doctor’s office and at home. But hundreds more doctors have been waiting for FDA’s approval of Aimmune’s version, a designated capsule that contains powder derived from peanut flour and holds peanut proteins at consistent levels.