Skip to main content

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

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

By Lori Solomon HealthDay Reporter

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.

More Information

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.

© 2025 HealthDay. All rights reserved.

Read this next

Exposure Therapy For Peanut Allergy Effective In Adults

MONDAY, April 28, 2025 -- Adults with peanut allergies can be safely treated using exposure therapy to increase their resistance, new clinical trial results show. More than...

Antibiotics Might Increase Risk of Childhood Asthma, Allergies

WEDNESDAY, April 23, 2025 -- Overuse of antibiotics might increase kids’ risk of developing asthma and allergies, by disrupting their gut bacteria during a crucial stage of...

Allergy Expert Gives Tips On Seasonal Allergies

FRIDAY, April 18, 2025 -- Spring has sprung, and the battle with seasonal allergies is underway in earnest. But there’s a lot folks can do to manage their pollen-produced...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.