FDA Approves Odactra for Pediatric House Dust Mite Allergy
Conexiant
February 28, 2025
The FDA has approved Odactra for pediatric patients aged 5 to 11 years with house dust mite-induced allergic rhinitis.
Odactra was previously approved for patients aged 12 to 65 years and is developed by ALK.
The approval is based on data from the MT-12 trial, a phase III study involving 1,460 pediatric patients.
House dust mites are a leading cause of respiratory allergic disease, affecting over 10 million children globally.
Odactra is marketed internationally under various brand names and has received pediatric approval in Europe and Japan.
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