The Submitted Biologics Application for AR101, the first potential pediatric food allergy preventive therapy, will be considered on September 13.
There is a set decision date for the marketing application of AR101.
The US Food and Drug Administration (FDA) has informed Aimmune Therapeutics that its Allergenic Products Advisory Committee (APAC) will review the Biologics License Application (BLA) for investigative peanut allergy therapy AR101 on September 13.
If the APAC approves the application, the biologic will become the first therapy indicated for food allergy desensitization and anaphylaxis risk reduction on the US market.
The BLA for AR101 was originally accepted in March 2019, with an original review target date of late January 2020. The biologic was previously granted Fast Track and Breakthrough Therapy designations for peanut-allergic children and adolescents aged 4-17 years old. The once-daily peanut allergen therapy gradually desensitizes patients from allergic reactions, symptoms, and anaphylaxis.
The AR101 application was supported by data from the pivotal phase 3 PALISADE trial, in which 555 patients who reacted to ≤ 100 mg of peanut were randomized 3:1 in a double-blind, placebo-controlled food challenge. Patients were treated with either AR101 or placebo on an escalating-dose regimen. Average patient age was 11.3 years (range 4-49), and 406 (74%) had a history of peanut anaphylaxis prior to screening.
Patients received therapy over the course of 24 weeks, and those who completed the regimen participated in a double-blind, placebo-controlled food challenge to gauge progress. At the exit food challenge, 250 (67.2%) of patients who had received AR101 were able to ingest ≥ 600 mg peanut protein without dose-limiting symptoms, compared to just 5 (4%) of patients who had received placebo (95% CI, 53.0 — 73.3; P <.001).
Jayson Dallas, MD, president and chief executive officer of Aimmune, said the company will continue to refine preparations ahead of the September 13 decision they are in the best position “preparations, for the September 13 APAC Meeting so that we are in the best position to introduce AR101 to patients and their families as the first-ever approved treatment for peanut allergy, indeed for any food allergy.”
“As we have previously communicated, we will be ready to launch AR101 by the fourth quarter of this year,” Dallas said in a statement.
In an interview with MD Magazine® while at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2019 Annual Meeting in San Francisco, CA, this year, Edwin Kim, MD, MS, and Scott Commins, MD, PhD—colleagues from the University of North Carolina School of Medicine—said they anticipate investigators will continue to look at the oral therapy—and its potential competitors—in younger and younger food allergy patients.
“I think at this stage, the data from all different modalities—oral, epicutaneous, even sublingual—seemed to suggest not that it can't work in older populations, but seems to have a stronger benefit in younger populations,” Kim explained. “In particular, when you think of something like oral, it seems like it might be better tolerated in the younger groups.”
The pair also wondered what real-life outcomes are potentially available to post-immunotherapy patients, as recent studies have shown varying capabilities of daily peanut consumption per patient.
“Whatever it might be, it seemed to show that many were actually able to do it‚ which I think is important on multiple levels,” Kim noted. “One of them is just being able to open up the diet a little bit, maybe relieve some of that anxiety that inherently comes the allergy.”