FDA approves Palforzia, first peanut allergy treatment for children
The FDA announced that it approved the oral immunotherapy Palforzia, the first treatment for peanut allergy in children aged 4 to 17 years.
According to the FDA and the product’s manufacturer, Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp, Aimmune Therapeutics) is a powder made from peanuts. The product is packaged in pull-apart color-coded capsules that are emptied and mixed with a small amount of semisolid food that the patient consumes in a dosing regimen spread out over several months. It is only available through the FDA’s Risk Evaluation and Mitigation Strategy (REMS) — the drug safety program that, according to the FDA’s website, can require “for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
“We believe that the Palforzia development program — the largest, most robust dataset ever assembled for a therapeutic approach to peanut allergy — has set the standard for demonstrating robust efficacy and acceptable safety using an established therapeutic approach that builds on a century of oral immunotherapy research,” Steve Tilles, MD, senior director of medical affairs at Aimmune Therapeutics, told Healio Primary Care.
Andrew Oxtoby, chief commercial officer at Aimmune Therapeutics, said the peanut allergen powder “is a complex biologic drug that is a rigorously developed, pharmaceutical-grade oral immunotherapy for peanut allergy with a well-defined allergen profile to ensure that every dose, whether 0.5 mg (equivalent to 1/600th of a peanut) or 300 mg, has been prepared and analyzed for consistency.” He noted that that the biologics license application for the peanut allergen powder included efficacy and safety data from seven clinical studies. Some of these studies were covered by Healio.
Oxtoby also stated that the wholesale acquisition cost of the medication is $890 per month but assistance programs could lower the cost to $20 per month. In patients without coverage, the medication could be free. He noted that the peanut allergen powder should be available in “a matter of weeks.” As previously reported by Healio Primary Care, Aimmune Therapeutics will also provide programs for patients, physicians and their staffs to support the product’s launch. – by Janel Miller
Reference: FDA. Risk Evaluation and Mitigation Strategies/REMS. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems. Accessed Feb. 3, 2020.
Disclosures: Oxtoby and Tilles are employed by Aimmune Therapeutics.