The US Food and Drug Administration (FDA) has officially approved the nation’s first treatment for peanut allergies.
The drug, which is being marketed as Palforzia by biopharmaceutical company Aimmune Therapeutics, is also the first approved therapy for any food allergy.
The FDA approved the oral immunotherapy drug for commercialization and development earlier this week. The drug consists of a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for dose escalation and up-dosing. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food—such as applesauce, yogurt, or pudding—which the patient then consumes.
The treatment has been designed to mitigate allergic reactions—including anaphylaxis—and reduce the risks of accidental exposure to peanuts.
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The treatment consists of three phases: Initial Dose Escalation, Up-Dosing, and Maintenance. The Initial Dose Escalation phase is given on a single day. The Up-Dosing phase consists of 11 increasing dose levels and occurs over several months. Initial Dose Escalation, and the first dose of each Up-Dosing level, are administered under supervision of a healthcare professional in a healthcare setting with the ability to manage potentially severe allergic reactions, including anaphylaxis.
While anaphylaxis can occur at any time during Palforzia therapy, patients are at highest risk during and after the Initial Dose Escalation and the first dose of each Up-Dosing level. During Up-Dosing, if the patient tolerates the first dose of an increased dose level, the patient may continue that dose level daily at home. After a patient completes all Up-Dosing levels, they may begin the daily maintenance dose.
Although the drug will only be made available to children under the age of 17 years old through certain clinics and certified healthcare settings, it is being hailed as a landmark moment for treating one of the nation’s most common food allergies.
“This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families,” said Jayson Dallas, President and CEO of Aimmune Therapeutics. “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,” he added.
The safety of Palforzia was assessed in two double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals. All of them were tested and diagnosed with extreme sensitivities to peanuts, with a median peanut tolerance of about 10 milligrams.
By the end of the year-long trial, two-thirds of the young participants were able to ingest the researchers’ goal of 600 milligrams of peanut protein (roughly two peanuts worth) without displaying any allergic symptoms. Half of the patients were then able to go on and ingest 1,000 milligrams of peanut protein without any reactions.
“Not only is Palforzia the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy,” said Daniel Adelman, Chief Medical Officer of Aimmune Therapeutics. “We truly appreciate the efforts of the peanut allergy community who contributed to the development of Palforzia—including the more than 1,200 patients and their families who participated in our clinical trials, the study investigators and their staff, the advocacy community, and our dedicated employees—all of whom have helped us develop and deliver this first-of-its kind therapy.”
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