The U.S. Food and Drug Administration has expanded the indication for a sublingual allergy immunotherapy tablet (Odactra) to include pediatric patients aged 5 to 11 years with house dust mite–induced allergic rhinitis with or without conjunctivitis. The tablet, developed by ALK, was previously approved in patients aged 12 to 65 years. The expanded approval aligned with ALK’s strategy to broaden access to its respiratory allergy immunotherapy products across all age groups.

Henriette Mersebach, MD, Executive Vice President of Research and Development at ALK, stated that the approval provides an additional treatment option among pediatric patients with house dust mite allergy. The company plans to make its allergy immunotherapy tablet available through U.S. prescriber networks and commercial and government markets, according to a press release from GlobeNewswire.

The U.S. Food and Drug Administration's decision was based on data from the MT-12 trial, a phase III study involving 1,460 pediatric patients across North America and Europe. The trial demonstrated the efficacy and safety of the allergy immunotherapy tablet in the pediatric population, with findings published in The Lancet Regional Health–Europe. House dust mites are a leading cause of respiratory allergic disease and are associated with asthma. More than 10 million children aged 5 to 11 years across the world are estimated to have uncontrolled respiratory allergies.

The allergy immunotherapy is marketed internationally under different brand names, including Acarizax in Europe, Miticure in Japan, and Sensimune in India. The product has been approved for pediatric use in Europe and Japan, with a regulatory review ongoing in Canada. A separate review of Itulazax, ALK’s tree pollen allergy immunotherapy tablet, is also in progress in Europe and Canada, with completion expected in 2025.