The U.S. FDA has expanded the approval of Denmark-based ALK-Abelló’s Odactra tablets to include the treatment of house dust mite allergies in children ages five through 11 years.
First approved in 2017 for patients 18 through 65 years of age, the once-daily allergy immunotherapy tablet dissolves under the tongue and is designed to help patients reduce their allergy symptoms and reliance on symptomatic medication. The drug was originally submitted to the FDA by Merck (MSD) under a partnership with ALK, but following the end of the partnership, ALK took over the rights to the tablet portfolio in North America.
The expanded approval was based on positive data from the largest-ever pediatric allergy immunotherapy tablet phase 3 clinical trial, MT-12, which involved 1,460 children in North America and Europe.
Odactra is marketed as Acarizax in Europe and Miticure in Japan where it is already approved for use in young children.