FDA Accepts AR101 BLA for Peanut Allergy

The US Food and Drug Administration (FDA) has accepted Aimmune’s Biologics License Application for AR101. The therapy is seeking approval as a treatment to reduce the risk of anaphylaxis in peanut-allergic children and adolescents following exposure to peanut.

“Every day in the United States, more than one million children and teens with peanut allergy are at risk that exposure to food allergens could lead to potentially life-threatening reactions,” said Daniel Adelman, MD, Chief Medical Officer of Aimmune.

AR101 has previously received Breakthrough Therapy Designation (in June 2015) as well as Fast Track Designation (in September 2014). Both of these designations support an expedited FDA review process, however, the FDA indicated that the AR101 BLA will be reviewed under a 12-month timeline. This places the target date for regulatory action in late January 2020.

“We are working with the FDA to complete their review as expeditiously as possible given that there are currently no approved medicines for peanut allergy,” noted said Jayson Dallas, MD, President and Chief Executive Officer of Aimmune.

There are currently no FDA-approved therapies for this indication, but an application for competitor product Viaskin Peanut is expected to be submitted to the FDA in the second half of 2019.

The AR101 BLA was supported by data, including results from the pivotal phase 3 PALISADE trial. The trial included 555 patients who reacted to ≤ 100 mg of peanut in a double-blind, placebo-controlled food challenge. These patients were randomized 3:1 to either AR101 or placebo on an escalating-dose regimen. Participants averaged 11.3 years of age (range 4-49) and 406 (74%) had a history of peanut anaphylaxis prior to screening.

Patients received AR101 or placebo in a dose-escalating program over the course of 24 weeks. Those who completed the regimen participated in a 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).

“Published epidemiologic studies and everyday experiences of this community show that for many, avoidance of peanuts is not enough. There is an urgent need for a rigorously developed, clinically proven medicine like AR101 that can help protect people when accidental exposures do occur,” said Adelman.

At the American Academy of Allergy, Asthma & Immunology (AAAAI) 2019 Annual Meeting in San Francisco, MD Magazine® spoke with David Stukus, MD, of the Nationwide Children’s Hospital and the Ohio State University College of Medicine about AR101.

“So, when we think about the immunotherapy options that are going to be available for food allergy in the near future, we have the oral immunotherapy AR-101, which shows very promising results and the ability to increase the threshold dose that would cause a reaction among children who have peanut allergy,” said Stukus.

Stukus added that providers must be clear with parents of peanut-allergic children that the oral immunotherapy treatment doesn’t provide a cure and that daily exposure to a therapeutic dose is necessary.