FDA Expands Odactra Label to Include Children Aged 5-11 for Dust Mite-Induced Allergic Rhinitis

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The FDA has approved a label expansion for ALK’s Odactra, extending its indication to include pediatric patients between five and 11 years of age for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. The approval was partially based on results from a Phase III trial that was the largest pediatric trial of HDM allergen immunotherapy to date, according to ALK.¹

"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,” said Jackie Eghrari-Sabet, MD, allergist, immunologist, clinical assistant professor, George Washington University School of Medicine, in a press release.

The randomized, double-blind, placebo-controlled Phase III trial randomly assigned 1,458 children in a 1:1 ratio receive either Odactra or placebo for one year. The primary endpoint of the study was the total combined rhinitis score (TCRS) during the final eight weeks of treatment. Secondary endpoints included total rhinitis daily symptom score, medication score, rhino conjunctivitis total combined score, and the Pediatric Rhino Conjunctivitis Quality of Life Questionnaire score.

Results demonstrated a 22% reduction in TRCS scores. For the secondary endpoints, Odactra significantly reduced symptoms and medication use, and improved disease-related quality of life, compared to placebo.^1,2

The safety profile of Odactra was consistent with the data observed in older populations, with most adverse events (AEs) mild to moderate in nature. The most common AEs included throat irritation/tickle; itching in the mouth or ears; swelling of the back of the mouth, lips, or tongue; tongue pain; nausea; throat swelling; stomach pain; sore on the tongue; sore in the mouth; diarrhea; vomiting; and food tasting different. Four patients in the Odactra arm experienced severe treatment-related AEs, including oral pruritus, ear pruritus, glossodynia, lip swelling, and abdominal pain.¹

According to Medscape, allergic rhinitis affects approximately 19.2 million people in the United States annually. In 80% of all cases, it develops before a patient reaches 20 years of age. Globally, 10% to 30% of all adults and around 40% of children have experienced allergic rhinitis. In pediatric patients, it is more common in males, but the prevalence is around the same level for both men and women in adulthood.

Allergic rhinitis is often connected to asthma, otitis media, eustachian tube dysfunction, sinusitis, nasal polyps, allergic conjunctivitis, and atopic dermatitis. While not directly life-threatening, allergic rhinitis can worsen these conditions and contribute to increased morbidity. For example, in patients with asthma, it can exacerbate inflammation and increase the risk of severe complications. Additionally, allergic rhinitis can affect quality of life, leading to symptoms such as fatigue and drowsiness.³

"With the expanded pediatric approval of Odactra in the US, younger children can now be treated with a sub-lingual tablet, in addition to adolescent and adult patients, who experience allergy symptoms due to house dust mites. We are proud to build upon our longstanding commitment to patients developing evidence-based innovative medications like Odactra and continue our 100-year legacy of pioneering in the field of respiratory allergies,” said Judit Nyirady, MD, MBA, SVP, global chief medical officer, ALK, in the press release.

References

1. U.S. 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. PR Newswire. February 28, 2025. Accessed February 28, 2025. https://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. 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 randomized, double-blind, placebo-controlled, phase III trial. ScienceDirect. Accessed February 28, 2025. https://www.sciencedirect.com/science/article/pii/S2666776224003053#sec3

3. Allergic Rhinitis. Medscape. Accessed February 28, 2025. https://emedicine.medscape.com/article/134825-overview#a6