FDA Approves House Dust Mite Allergy Therapy For Use in Young Children

The FDA approved an expanded label for a house dust mite allergen tablet (Odactra) for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. The expanded approval will now include patients aged 5 through 11 years in addition to ages 12 through 65 years.¹

Odactra is an allergy immunotherapy that is administered sublingually. | Image Credit: penyushkin | stock.adobe.com

"The pediatric indication for Odactra is significant because it provides physicians and parents a new option for treating these younger patients. In addition to the convenience of sublingual administration, Odactra has been shown to reduce their allergy symptoms and reliance on symptomatic medications. Allergy symptoms such as nasal congestion, sneezing, and watery eyes can have a significant impact on a child's life,” Jackie Eghrari-Sabet, MD, allergist and immunologist and clinical assistant professor at the George Washington University School of Medicine, said in a news release.¹

Odactra is an allergy immunotherapy that is administered sublingually. The mode of administration can improve access to treatment for this patient population since other prescription allergy treatment options require regular injections. The approval is based on a phase 3 study (NCT04145219), which is the largest pediatric trial for HDM allergen immunotherapy in children published to date, according to the news release.¹

Investigators aimed to establish the efficacy of the sublingual tablet compared to the placebo for children aged 5 to 11 years of age with HDM allergic rhinitis. They used the total combined rhinitis symptoms and medication score to establish efficacy in the last 8 weeks of treatment. The safety and tolerability were also assessed, including whether the treatment had an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life.²

Patients included in the study received either the investigational treatment or the matching placebo and allergy and asthma rescue medication. The primary end point included the average daily total combined rhinitis symptoms and medication score during the primary efficacy assessment period at 8 weeks. Secondary end points included the average rhinitis daily symptom score and the daily medication score during the primary efficacy assessment period and the overall pediatric rhinoconjunctivitis quality of life questionnaire score.²

There were 1458 patients included in the study from September 29, 2019, and April 1, 2022. Approximately 95.5% completed treatment, and 95.9% completed the study. Investigators found that the absolute treatment difference for the primary end point of the study drug and the placebo was 1.0 (95% CI: 0.5, 1.4; p < 0.0001), corresponding to a relative reduction of approximately 22%. Additionally, investigators found that the sublingual tablet reduced symptoms and medication use and improved disease-related quality of life compared with the placebo. The results were consistent across subgroups of patients with and without asthma at baseline.³

The drug also showed a favorable safety profile, with treatment-related adverse events including local application-site reactions, such as oral pruritus, throat irritation, and ear pruritus. Although there was a higher frequency in the drug group compared with the placebo, few events led to treatment discontinuation.³

READ MORE: Allergy Resource Center

Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.

REFERENCES

1. US FDA approves label expansion for ALK’s Odactra (house dust mite allergen tablet) for sublingual use as immunotherapy to now include children with house dust mite allergy. News release. ALK. February 28, 2025. Accessed February 28, 2025. http://prnmedia.prnewswire.com/news-releases/us-fda-approves-label-expansion-for-alks-odactra-house-dust-mite-allergen-tablet-for-sublingual-use-as-immunotherapy-to-now-include-children-with-house-dust-mite-allergy-302388155.html

2. House Dust Mite Allergy Trials in Children (MATIC). ClinicalTrials.gov ID: NCT04145219. June 12, 2024. Accessed February 28, 2025. https://clinicaltrials.gov/study/NCT04145219

3. Schuster A, Caimmi D, Nolte H, et al. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024;48:101136. Published 2024 Nov 26. doi:10.1016/j.lanepe.2024.101136