FDA to ask panel if Aimmune peanut allergy treatment data support approval
The FDA has posted briefing documents ahead of its Allergenic Products Advisory Committee Meeting on September 13, which is being called to review the biologics license application submitted by Aimmune Therapeutics for its peanut allergen powder with the proposed trade name Palforzia. The Committee will be asked whether the efficacy and safety data support licensure of Palforzia 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 of age with a confirmed diagnosis of peanut allergy. The FDA summary of the data supporting the application states in part: The pre-specified efficacy success criterion for the Phase 3 study, ARC003, was met for subjects 4 through 17 years of age. The difference between Palforzia and placebo groups in proportion of subjects able to ingest 600 mg of peanut protein with no more than mild symptoms during the DBPCFC at study end was 63.2% with a 95% CI. While not evaluated as an efficacy outcome, adverse events related to subject-reported accidental food allergen exposures decreased from 11.5% during up-dosing to 9.0% during maintenance in the Palforzia treatment group, further suggesting that Palforzia protects against allergic reactions following accidental exposure...Treatment with Palforzia resulted in an increased risk of systemic allergic reactions, some of which resulted in increased epinephrine use compared to the placebo treated group. In the controlled population, during initial dose escalation and up dosing combined, 9.4% of subjects taking Palforzia reported systemic allergic reactions while 3.8% of subjects in the placebo group did."