Analysis Shows Long-Term Safety and Efficacy of PALFORZIA

Earlier this morning, Aimmune Therapeutics announced the publication of a longitudinal analysis that recorded the safety, efficacy, and good allergy-related quality of life of long-term treatments for the oral immunotherapy PALFORZIA in patients with peanut allergy.

PALFORZIA was approved by the US Food and Drug Administration (FDA) in January 2020 as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.

The analysis noted an increased ability to tolerate higher doses of peanut during the food exit challenge, a result of daily therapeutic dosing of the drug for up to 2 years in patients 4-17 years old.

A decrease in the frequency of adverse events (AEs) was also recorded.

Long-term safety and efficacy of daily PALFORZIA was recorded in the ARC004 open-label follow-on study, which collected data from the start of the prior PALISADE study through the end of ARC004 approximately 28-56 weeks. Patients who enrolled in the ARC004 study were exposed to 1.5-2 years of treatment with PALFORZIA.

The PALISADE-ARC004 study found that more than 80% of patients were able to reach and tolerate the daily dose of 2000 mg, which was a considerably higher dose than the patients had previously experienced (125 mg).

Safety analyses included the incidence of treatment-emergent AEs (TEAEs), both related and unrelated, including serious AEs, during the overall study period.

Additionally, the total number of treatment emergent adverse events decreased, and an ongoing immunomodulation involving the decrease of IgE levels and increase of IgG4 levels were recorded,

“The long-term data from this analysis reinforce that ongoing treatment with PALFORZIA can help reduce that burden and improve the quality of life of patients and their caregivers, while also continuing to increase desensitization to peanut protein over time with fewer adverse events,” said Louise Peacock, Global Head of Research and Development for Aimmune Therapeutics.

“We are encouraged by these results and committed to gathering additional data to help assess the benefits of PALFORZIA in a real-world setting.”

The data, “Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy”, were published online in Allergy: European Journal of Allergy and Clinical Immunology.