FDA expands label for Odactra dust mite allergen tablet to children 5-11 years
The expanded indication now includes children aged 5 through 11 years, in addition to patients aged 12 to 65 years.
FDA expands label for Odactra dust mite allergen tablet to children 5-11 years | Image Credit: © Calin - © Calin - stock.adobe.com.
On February 28, 2025, the FDA approved an expanded indication for ALK's House Dust Mite Allergen Tablet (Odactra) to treat house dust mice (HDM)-induced allergic rhinitis, with or without conjunctivitis, to include children aged 5 to 11 years, according to an announcement from ALK.1
HDM-induced allergic rhinitis often starts in childhood and can negatively impact a child's quality of life.2
Odactra, an allergy immunotherapy, is administered sublingually as a small tablet that dissolves under the patient's tongue. This option, according to ALK, is important because children within the indicated age range can have a difficult time with other prescription allergy treatment options that require injections.1
"The pediatric indication for ODACTRA is significant because it provides physicians and parents a new option for treating these younger patients," said Jackie Eghrari-Sabet M.D., Allergist & Immunologist and Clinical Assistant Professor at the George Washington University School of Medicine, in a statement.1
"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 Eghrari-Sabet.1
Approval was partly based on data from a phase 3 clinical trial that featured 1458 children aged 5 to 11 years, the largest pediatric trial of any HDM allergen immunotherapy in children.1
The trial was a randomized, double-blind, placebo-controlled, that evaluated the efficacy and safety of the newly-approved therapy in the newly-indicated age range. Patients in the trial had a clinical history of physician-diagnosed HDM-induced allergic rhinitis/conjunctivitis (AR/C) for at least 1 year with or without a clinical history of asthma, and persistent allergic rhinitis symptoms despite receiving symptom-relieving medication.1
Change in total combined rhinitis score (TCRS) during the first 8 weeks of the 1-year treatment period was the primary outcome of the trial. The World Allergy Organization proposed clinically relevant efficacy as ≥ 20% difference between active and placebo in clinical endpoints that include symptom score and/or daily medication use, stated ALK.1
"In the study, children treated with ODACTRA (n=693) experienced a relative reduction in TCRS of 22% (95% CI: 12.0; 31.1) versus placebo (n = 706)," the company noted, with an observed safety profile consistent with the established profile seen in adults and adolescents.1
"Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo," stated authors of the study in a Lancet Regional Health Europe publication.2
Most adverse events were mild or moderate, with 4 of the 727 patients in the Odactra group having experienced severe treatment-related adverse events, which included oral pruritus, ear pruritus, glossodynia, lip swelling, and abdominal pain. Including the placebo group, 1.8% of patients discontinued the study because of an adverse event while exposed to Odactra.1
No participants ages 5 through 11 years treated with Odactra reported treatment-related serious AEs, treatment-related anaphylaxis, or AEs requiring treatment with epinephrine.1
"The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5–11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children," stated study investigators at the time of the Lancet Regional Health Europe publication.2
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. ALK. Press 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. The Lancet Regional Health - Europe. Volume 48. 2025. doi:10.1016/j.lanepe.2024.101136.
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