Aimmune Wins FDA Approval for First Peanut Allergy Treatment

For the millions of people suffering from an allergy to peanuts, there is a new, first-of-its-kind treatment available. On Friday, the U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy AR101.

For the millions of people suffering from an allergy to peanuts, there is a new, first-of-its-kind treatment available. On Friday, the U.S. Food and Drug Administration (FDA) approved Aimmune Therapeutics oral immunotherapy AR101, which will be sold under the brand name Palforzia.

Palforzia was approved under Fast Track Review for use in pediatric patients, ages 4 to 17, who have been diagnosed with an allergy to peanuts, which can be deadly due to potential anaphylaxis. The approval marks a first for those battling peanut allergies. Prior to its full approval, Palforzia was overwhelmingly supported by the Allergenic Products Advisory Committee, which reviewed the data. The committee supported approval of the drug by a vote of 7-2 in support of efficacy and 8-1 for safety.

Shares of Aimmune are up more than 16% in premarket trading today to $36.04.

Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] is an oral treatment indicated to mitigate allergic reactions to peanuts. As an oral immunotherapy, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, resulting in the ability to mitigate allergic reactions to the allergen over time. The medication is intended for use with a diet that recommends the avoidance of peanuts. It is not approved for the emergency treatment of allergic reactions, including anaphylaxis, which means patients with a confirmed peanut allergy may still need their emergency treatments, such as the Epi-Pen Auto injector.

Jayson Dallas, president and chief executive officer of Aimmune Therapeutics, said the approval of Palforzia is a “defining moment” for people who have peanut allergies, as well as for the company itself. He said it was exciting to become the first company with an FDA-approved treatment for peanut allergy. The list price for the treatment has been set at $890 per month or $11,000 per year.

“Our commercial field team is ready to begin engaging with allergists to help them prepare to safely incorporate Palforzia into their practices and, with approval in hand, our payer team can also immediately begin work to secure formulary access to Palforzia. We view this approval as just the beginning for Aimmune, and it underscores our continued commitment to bringing innovative treatments to people with potentially life-threatening food allergies,” Dallas said in a statement.

Daniel Adelman, chief medical officer for Aimmune, said Palforzia is the first approved therapy for any food allergy in the United States.

Phase III data showed Aimmune’s peanut allergy therapy was effective in more than 67 percent of juvenile patients. Aimmune said 67.2% of juveniles ages four to 17 who were administered AR101 in the Palisade trial could tolerate exposure of at least a 600-mg dose of peanut protein in the exit food challenge. Only 4 percent of patients on the placebo could tolerate that amount, the company said when the data was announced. It was that data that supported Aimmune’s Biologics License Application. The FDA is set to make a decision on Palforzia in early 2020. In June 2015, Aimmune won Breakthrough Therapy Designation status from the U.S. Food and Drug Administration (FDA) for Palforzia.

It is estimated there are more than 1.6 million children and teens in the United States who have a peanut allergy of some kind. Palforzia will only be available to patients through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include: the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment; the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients, and pharmacies/distributors must be certified with the REMS.

Aimmune’s Palforzia may not be the only company with an approved peanut allergy treatment. In August, France-based DBV Technologies re-submitted a Biologics License Application to the FDA for its Viaskin Peanut treatment, its non-invasive allergy patch. The company anticipates action from the regulatory agency regarding the resubmitted BLA in August 2020.