The FDA has expanded its approval of ALK’s Odactra, a sublingual allergen extract to treat house dust mite (HDM)-induced allergic rhinitis, to adolescents ages 12 through 17.

Odactra was first launched for adults, ages 18 through 65, in the U.S. in 2017. The allergen extract is indicated as immunotherapy for HDM-induced allergic rhinitis, with or without conjunctivitis.

“In many cases, for adolescents experiencing allergy symptoms throughout the year, house dust mites may be the underlying allergy trigger,” says Michael Blaiss, MD, clinical professor of pediatrics, division of allergy/immunology at the Medical College of Georgia at Augusta University. “Allergies interfere with a critical time of adolescent development when they undergo physical, cognitive, emotional, and social changes. Odactra sublingual immunotherapy treats house dust mite allergy and can even help those polysensitized patients manage their symptoms.”

Data from several studies served as the basis for the expanded indication. The studies included a 28-day, phase 3 trial that evaluated the safety of Odactra in European adolescents ages 12 to 17 with HDM allergic rhinitis, with or without conjunctivitis and with or without mild asthma.

The trial’s primary endpoint of at least one treatment-emergent adverse event (TEAE) was reported in 223 (88%) subjects and confirmed data from previously conducted North American and Japanese trials indicating that the HDM sublingual immunotherapy tablet was well tolerated in adolescents with HDM allergic rhinitis, with or without conjunctivitis.

According to the manufacturer, the safety profile in children and adolescents was consistent with the safety profile in adults. No treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trials.

The most common treatment-related adverse events (TRAE) were local application site reactions. Most TRAEs were mild in intensity and were typically experienced during the first one to two days of treatment. Odactra is not indicated for the immediate relief of allergic symptoms.