The US Food and Drug Administration (FDA) has approved its first treatment for patients with peanut allergy - Aimmune’s Palforzia (AR101).
The drug, an oral immunotherapy indicated for the mitigation of allergic reactions, is now is approved for use in patients with a confirmed diagnosis of peanut allergy who are four years or older.
It is, however, not indicated for the emergency treatment of allergic reactions, including anaphylaxis and should be used in conjunction with a peanut-avoidant diet.
The approval marks a “defining moment” for the peanut allergy community and for Aimmune Therapeutics, which said it is “excited to bring the first FDA-approved treatment for peanut allergy to patients and their families,” according to Jayson Dallas, president and chief executive officer of Aimmune Therapeutics.
He continued, “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.”
The company also confirmed that the complex biologic drug is only available through a Risk Evaluation and Mitigation Strategy (REMS).
Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone.