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

Follow Drugslib on

Medically reviewed by Drugs.com.

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.

Source: HealthDay

Posted : 2025-03-06 12:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords