WASHINGTON — Aimmune Therapeutics’ oral immunotherapy for peanut allergy gained FDA approval late Friday, for treating individuals age 4-17, the agency said.

To be sold as Palforzia, the product consists of purified peanut proteins, to be administered in carefully controlled escalating doses. The approval comes with a mandatory Risk Evaluation and Mitigation Strategy (REMS) to minimize the incidence of anaphylaxis during treatment, cases of which were observed during clinical trials.

Under the REMS, prescribers must undergo specific training. Moreover, the FDA said, “the Initial Dose Escalation phase and first dose of each Up-Dosing level must only be administered to patients in a certified healthcare setting equipped to monitor patients and to identify and manage anaphylaxis.”

Patients and/or parents or caregivers must also keep epinephrine injectors on hand at all times, since the treatment is not 100% effective and exposure to peanuts can be difficult to avoid in the real world. Patients receiving Palforzia treatment will still be counseled to avoid peanuts as much as possible.

But the drug still made a considerable difference in patients’ reactions to peanuts during the product’s trials. In a randomized study involving some 500 allergic individuals, 67.2% were eventually able to tolerate 600 mg of peanut protein in a supervised challenge, compared with just 4% of the placebo group.

At a September FDA advisory committee meeting, members voted 7-2 in favor of recommending approval. The main objection was the risk of anaphylaxis and other adverse events, which were twice as common with Palforzia compared with placebo. And, overall, 29 severe or life-threatening allergic reactions developed in patients receiving Palforzia versus four in the placebo group.

Another potential downside is that clinical studies with this and other immunotherapies for peanut allergy have indicated that therapy must continue indefinitely, as tolerance decreases once treatment stops.

Aimmune didn’t immediately indicate what it plans to charge for Palforzia.

Last Updated January 31, 2020