FDA Approves Odactra Label Expansion to Include Children With House Dust Mite Allergy

The FDA expanded its indication of house dust mite allergen tablets (Odactra; ALK-Abello A/S) for the treatment of patients aged 12 through 65 years with house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, to now include children aged 5 through 11 years.¹ Phase 3 study results, which were published in The Lancet Regional Health—Europe, contributed to the FDA’s decision on the updated indication.^1,2

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Odactra is an allergy immunotherapy indicated to treat HDM-induced allergic rhinitis. It is administered sublingually as a small tablet that dissolves under the tongue. Having this administration option available for parents with children who meet the treatment requirements is significant because many young children may have difficulty with other prescription allergy treatment options that require regular subcutaneous injections or swallowing pills.¹

Odactra works by treating the underlying cause of environmental allergies using the patient’s own immune system. Small amounts of allergens are introduced into the body, allowing the immune system to gradually learn how to tolerate them better. It targets the specific allergy trigger that causes the immune system to overreact, providing long-lasting improvement for years after treatment.¹

The updated indication was partially approved based on results from a double-blind, randomized, placebo-controlled, 1-year phase 3 trial (NCT04145219)³, which evaluated Odactra in patients aged 5 to 11 years with HDM allergic rhinitis or rhinoconjunctivitis, with or without asthma. A total of 1460 patients were randomly assigned to receive either sublingual Odactra (n = 729) or placebo once per day (n = 731). The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period. Secondary outcomes included the following: rhinitis daily symptom score (DSS) and medication score (DMS); the rhinoconjunctivitis total combined score (TCS); and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score.^2,3

The data indicated that the primary outcome was statistically different for patients receiving Odactra versus placebo, with an absolute difference in TCRS scores of 1.0 (95% CI: 0.5, 1.4; P < .0001). This corresponded to a relative reduction of about 22.0% (95% CI: 12.0, 31.1), according to the investigators.²

“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, immunologist, and clinical assistant professor at the George Washington University School of Medicine, said in a news release.¹

Key secondary outcomes were also met and showed statistically significant reductions in symptoms and medication use, as well as improved disease-related quality of life for patients taking Odactra compared with placebo. Additionally, improvements in asthma symptoms and reduced asthma medication use also indicated an additional effect.²

The investigators observed a higher event rate for treatment-related adverse events (AEs) in the Odactra group compared with placebo. The most common events were either mild or moderate in severity and included oral pruritus, ear pruritus, glossodynia, lip swelling, and abdominal pain. Only 2.5% of participants discontinued because of their AEs. The safety profile demonstrated in the study was considered to be consistent with the established safety profile for both adult and adolescent patients.^1,2

“With the expanded pediatric approval of Odactra in the US, younger children can now be treated with a sublingual tablet, in addition to adolescent and adult patients who experience allergy symptoms due to house dust mites,” Judit Nyirady, MD, MBA, SVP, global chief marketing office, ALK, said in the news release.¹

REFERENCES

1. Allergen Tablet) for Sublingual Use as Immunotherapy to Now Include Children with House Dust Mite Allergy. News release. February 28, 2025. Accessed February 28, 2025. https://www.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. 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. 2025;48:101136. doi:10.1016/j.lanepe.2024.101136

3. House Dust Mite Allergy Trial In Children (MATIC). ClinicalTrials.gov identifier: NCT04145219. Updated June 12, 2024. Accessed February 28, 2025. https://clinicaltrials.gov/study/NCT04145219