The Food and Drug Administration (FDA)’s Allergenic Products Advisory Committee voted in favor of the approval of Palforzia (AR101; Aimmune Therapeutics) as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients 4 through 17 years old with a confirmed diagnosis of peanut allergy.
In March, Aimmune submitted a Biologics License Application (BLA) to the FDA for Palforzia; the submission included data from the phase 3 PALISADE trial which was intended to support the efficacy of the investigational immunotherapy. The study met its pre-specified success criterion for efficacy with a significantly greater proportion of patients being able to tolerate a dose of at least 600mg of peanut protein with no more than mild symptoms, compared with placebo (67.2% vs 4.0%, respectively; P<.0001).
With regard to safety, the data showed that Palforzia treatment was associated with an increased risk of systemic allergic reactions, some of which resulted in more epinephrine use when compared with placebo. To ensure safety, the Company proposed several risk management measures which included:
- Requirement of initial dose escalation and first dose of each dose-escalation level to be administered in a facility equipped to treat systemic allergic reactions
- Documentation that patients have an epinephrine prescription prior to initiation of treatment
- Distribution of Palforzia through specialty pharmacies
- Packaging designed so that patients only receive their appropriate dose
In addition, the Company proposed the inclusion of a Boxed Warning in the product labeling regarding the risk of systemic allergic reactions. “Patient safety has been central to us since the beginning of the Palforzia development program,” said Jayson Dallas, MD, President and Chief Executive Officer of Aimmune. “We look forward to working with the Agency to finalize our proposals, which we believe will support the safe and appropriate use of Palforzia.”
Palforzia is initially sourced as shelled, dry roasted peanut (Arachis hypogaea) allergen powder which is then evaluated to ensure a daily dose of peanut protein that includes major allergen content. The product is administered as an oral powder in graduated doses.
The BLA has been assigned a review action date of late January 2020. If approved, it would become the first therapy specifically indicated to treat a food allergy.
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