FDA expands indication of dust mite allergy drug to include young children

The U.S. Food and Drug Administration has expanded its indication of ALK’s 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 III 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.”

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