– ODACTRA is now indicated to treat house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in children ages 5 through 11 years, in addition to patients 12 through 65 years of age –
– House dust mites are a common cause of allergies in children and can cause symptoms year-round1 –
BEDMINSTER, N.J., Feb. 28, 2025 /PRNewswire/ — ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the U.S. Food and Drug Administration (FDA) expanded its indication of ODACTRA® (House Dust Mite Allergen Tablet) for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, to now include children ages 5 through 11 years, in addition to patients 12 through 65 years of age.2
ODACTRA is an allergy immunotherapy indicated to treat HDM-induced allergic rhinitis and is administered sublingually as a small tablet that dissolves under the tongue. Having this option available for parents with children who meet the treatment requirements is so important, as many children at this age can have a challenging time with other prescription allergy treatment options that require regular injections.
Jackie Eghrari-Sabet M.D., Allergist & Immunologist and Clinical Assistant Professor at the George Washington University School of Medicine, said: “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.“
Largest Pediatric Trial for House Dust Mite Allergy
The approval was based, in part, on data from a Phase 3 clinical trial in 1,458 children ages 5 through 11 years old and is the largest pediatric trial of any HDM allergen immunotherapy in children published to date. This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of ODACTRA in children ages 5 through 11 years with a clinical history of physician-diagnosed HDM-induced allergic rhinitis/conjunctivitis (AR/C) for at least one year with or without a clinical history of asthma, and persistent allergic rhinitis symptoms despite receiving symptom-relieving medication. Both the ODACTRA and placebo groups were allowed to take symptom-relieving allergy medications (including oral and ocular antihistamines and nasal corticosteroids) during the study as needed. The primary efficacy endpoint was assessment of change in total combined rhinitis score (TCRS) during the final eight weeks of the one-year treatment period.2 TCRS is a research measure that is a combination of the daily rhinitis symptom score and the daily medication score. 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.3
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 safety profile in the study was consistent with the established safety profile for adults and adolescents. Most adverse events (AEs) were mild or moderate. Among the evaluable safety population, ODACTRA (n=727) and placebo (n=731), four patients in the ODACTRA group experienced severe treatment-related AEs (TRAEs) which included oral pruritus (itching), ear pruritus, glossodynia (burning pain in the mouth), lip swelling, and abdominal pain. Across both treatment groups, 1.8% of participants discontinued the study due to an AE while exposed to ODACTRA.2 No participants ages 5 through 11 years treated with ODACTRA reported treatment-related serious AEs, treatment-related anaphylaxis, or AEs requiring treatment with epinephrine. The three most frequent TRAEs, reported in at least 2% of subjects in the ODACTRA group, were local application-site reactions including oral pruritus, throat irritation, and ear pruritus.2
The full results were published in the peer-reviewed publication, The Lancet Regional Health – Europe.
Judit Nyirady, MD, MBA, SVP, Global Chief Medical Office, ALK, added: “With the expanded pediatric approval of ODACTRA in the U.S., 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.“
About Sublingual Allergy Immunotherapy (SLIT)-Tablets
Allergy immunotherapy, or AIT, treats the underlying cause of environmental allergies using a person’s own immune system. Small amounts of allergens are introduced into the body so the immune system can gradually learn to tolerate them better. It targets the specific allergy trigger that causes the immune system to overreact and provides long-lasting improvement for years after treatment. SLIT-tablets are prescription medications that dissolve under the tongue and are taken once-daily at home, after the first dose is taken at the doctor’s office.4,5 SLIT-tablets offer an alternative treatment option for eligible patients who prefer to avoid allergy treatments administered through subcutaneous injection.
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media (ALK headquarters): Maiken Riise Andersen, tel. +45 5054 1434
Media: (ALK North America): Dan Commerford, tel. +1 908 842 8355
ODACTRA Indication
ODACTRA® (House Dust Mite Allergen Tablet) is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)–induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in individuals 5 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.
Selected Important Safety Information about ODACTRA
What is the most important information I should know about ODACTRA?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.
About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.
References
1InformedHealth.org. Overview: Dust mite allergies. Institute for Quality and Efficiency in Health Care (IQWiG). Available at: https://www.ncbi.nlm.nih.gov/books/NBK447098/. Accessed February 24, 2025.
2 ODACTRA. Prescribing information. ALK-Abelló, Inc.; Rev. 2025.
3 A. Schuster, D. Caimmi, H. Nolte, 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, 101136, ISSN 2666-7762.
4 Mayo Clinic. Allergy medications: Know your options. Available at: https://www.mayoclinic.org/diseases-conditions/allergies/in-depth/allergy-medications/art-20047403. Accessed February 14, 2025.
5 Gunawardana NC and Durham SR. New approaches to allergen immunotherapy. Ann Allergy Asthma Immunol. 2018;121(3):293-305.
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