On Feb. 27, 2025, ALK announced that the U.S. Food and Drug Administration (FDA) has approved ALK’s ODACTRA^® tablet for use in young children with house dust mite (HDM) allergy. ODACTRA^® is now indicated to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged five through 11, in addition to patients aged 12 through 65.  

ODACTRA^® is an allergy immunotherapy (AIT) tablet which dissolves under the tongue and helps patients reduce their allergy symptoms and their reliance on symptomatic medication.

The FDA approval is an important step in ALK’s efforts to make all its respiratory tablets available for all age groups – children, adolescents, and adults – in all relevant markets.

The data that formed the basis for the approval includes results from the largest-ever paediatric AIT Phase 3 clinical trial, MT-12, which involved 1,460 children in North America and Europe. The trial demonstrated efficacy and safety of the treatment in children, and the results were recently published in the reputable scientific journal, The Lancet Regional Health – Europe.