ALK announced that the U.S. Food and Drug Administration (FDA) approved ODACTRA® (House Dust Mite Allergen Extract) Tablet for Sublingual Use for the treatment of house dust mite (HDM)-induced allergic rhinitis in persons ages 12 through 17. ODACTRA was first launched for adults, ages 18 through 65, in the U.S. in 2017, and the expanded indication builds on ALK's treatment offerings for those suffering from allergies. ODACTRA is an allergen extract indicated as immunotherapy for HDM-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus HDMs, or skin testing to licensed HDM allergen extracts.

ODACTRA is approved for use in persons 12 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms. Data from several studies served as the basis for the expanded indication. The 28-day MT-18 trial was the first Phase 3 sublingual immunotherapy (SLIT)-tablet trial conducted only in adolescents.

It evaluated the safety of ODACTRA in European adolescents aged 12 to 17 years (N=253) with HDM allergic rhinitis with/without conjunctivitis (AR/C), with or without mild asthma. The MT-18 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 SLIT-tablet was well tolerated in adolescents with HDM AR/C. The safety profile in children and adolescents was consistent with the safety profile in adults, and no treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trials.3 The most common treatment-related adverse events (TRAEs) were local application site reactions. Most TRAEs were mild in intensity and were typically experienced the first one to two days of treatment.