A treatment for peanut allergies took another step toward becoming a reality as the Allergenic Products Committee voted to advise the U.S. Food and Drug Administration (FDA) this month during the approval process.
More than 1.6 million children and teens have been afflicted with peanut allergies, and reactions can be severe to the point of life-threatening consequences. According to a press release, the therapy could be approved early next year.
Jayson Dallas, president and CEO of Brisbane, California-based Aimmune Therapeutics, told FDA Health News how the treatment works.
"Research suggests that patients with food allergies can be desensitized to exposure to food allergens by ingesting controlled, increasing amounts of the allergen over a period of time," Dallas said in the press release. "Building on more than a century of research on oral immunotherapy (OIT) for food allergy, we are deploying a standardized approach called CODIT (Characterized Oral Desensitization Immunotherapy) to treat food allergies that is based on three key elements: a standardized OIT protocol with precise oral dosing, well-characterized pharmaceutical therapies and training and education."
Aimmune Therapeutics President and CEO Jayson Dallas
https://www.aimmune.com/
Dallas said Palforziea is administered orally every day in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food – such as applesauce or pudding.
"Palforzia involves a six-month process to precisely and carefully increase the dose every two weeks under the supervision of a trained allergist," Dallas said. "After that time, children and adolescents would reach the therapeutic daily dose of 300 mg – equivalent to the protein in one peanut – and continue to take therapeutic doses of Palforzia at home in order to maintain desensitization."
Dallas said the treatment has been successful during clinical trials.
"The therapy has proven to be quite successful as the data from our Palisade trial demonstrated that Palforzia increased tolerability, reduced the frequency and severity of allergic reactions, and also demonstrated an acceptable safety profile," Dallas said. "Sixty-seven percent of AR101 patients tolerated a single dose of at least two peanuts with no more than mild symptoms in the exit challenge, compared to 4 percent of placebo patients. Data from our Phase 3 Ramses trial confirmed the safety profile of Palforzia first observed in the Palisade study."
No price has been set yet for Palforzia.
"Aimmune’s overall goal will be to ensure that affordability is not an obstacle for any eligible patients, regardless of insurance or financial status," Dallas said. "The company intends to price Palforzia to reflect its value as a clinically proven, rigorously developed biologic oral immunotherapy treatment, and we will work closely with payers to achieve our goal of achieving access for eligible patients."
