The U.S. Meals and Drug Administration has expanded its indication of ALK’s Odactra, a home mud mite allergen pill, for the therapy of home mud mite-induced allergic rhinitis, with or with out conjunctivitis, to incorporate kids ages 5 by means of 11 years.
Odactra is an allergy immunotherapy and is run sublingually as a small pill that dissolves below the tongue.
The approval was primarily based on information from a Section III scientific trial that included 1,460 kids ages 5 to 11 years outdated with persistent allergic rhinitis signs for a yr, regardless of receiving symptom-relieving treatment. Kids randomly assigned to Odactra skilled a relative discount in complete mixed rhinitis rating of twenty-two p.c versus placebo.
4 sufferers receiving Odactra skilled extreme treatment-related antagonistic occasions, together with oral and ear itchiness, burning or tingling sensation within the mouth, lip swelling, and belly ache. Nevertheless, no individuals reported treatment-related anaphylaxis or antagonistic occasions requiring therapy 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 College in Washington, D.C., mentioned in a press release.
“In addition to the convenience of sublingual administration, Odactra has been shown to reduce their allergy symptoms and reliance on symptomatic medications.”
Extra data:
Extra Info
Antje Schuster et al, Efficacy and security of SQ home mud mite sublingual immunotherapy-tablet (12 SQ-HDM) in kids with allergic rhinitis/rhinoconjunctivitis with or with out bronchial asthma (MT-12): a randomised, double-blind, placebo-controlled, part III trial, The Lancet Regional Well being – Europe (2024). DOI: 10.1016/j.lanepe.2024.101136
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FDA expands indication of mud mite allergy drug to incorporate younger kids (2025, March 6)
retrieved 6 March 2025
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