Officials with the FDA have approved the allergy immunotherapy tablet Odactra (ALK) for use in young children with house dust mite allergy-induced allergic rhinitis, with or without conjunctivitis, in children aged 5 through 11 years, in addition to patients aged 12 through 65 years.1
The data that formed the basis for the approval includes results from the largest-ever pediatric allergy immunotherapy phase 3 clinical trial, MT-12, which involved 1460 children in North America and Europe. The trial demonstrated efficacy and safety of the treatment in children.
Globally, it is estimated that more than 10 million children, aged 5 to 11 years, have uncontrolled respiratory allergies, and the number is growing. House dust mites are a common cause of allergy and closely linked to asthma.
Reference
- ALK. FDA approves Odactra for the treatment of house dust mite allergy in young children [press release]. February 27, 2025. Accessed April 9, 2025. https://ir.alk.net/news-releases/news-release-details/fda-approves-odactrar-treatment-house-dust-mite-allergy-young