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FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children

By Lori Solomon HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on March 6, 2025.

via HealthDay

WEDNESDAY, March 5, 2025 -- The U.S. Food and Drug Administration has expanded its indication of Odactra, a house dust mite allergen tablet, for the treatment of house dust mite-induced allergic rhinitis, with or without conjunctivitis, to include children ages 5 through 11 years.

Odactra is an allergy immunotherapy and is administered sublingually as a small tablet that dissolves under the tongue.

The approval was based on data from a phase 3 clinical trial that included 1,460 children ages 5 to 11 years old with persistent allergic rhinitis symptoms for a year, despite receiving symptom-relieving medication. Children randomly assigned to Odactra experienced a relative reduction in total combined rhinitis score of 22 percent versus placebo. Four patients receiving Odactra experienced severe treatment-related adverse events, including oral and ear itchiness, burning or tingling sensation in the mouth, lip swelling, and abdominal pain. However, no participants reported treatment-related anaphylaxis or adverse events requiring treatment with epinephrine.

"The pediatric indication for Odactra is significant because it provides physicians and parents a new option for treating these younger patients," Jackie Eghrari-Sabet, M.D., an allergist and immunologist at George Washington University in Washington, D.C., said in a statement. "In addition to the convenience of sublingual administration, Odactra has been shown to reduce their allergy symptoms and reliance on symptomatic medications."

Expanded approval of Odactra was granted to ALK.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

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