ALK announced that the 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.
"In many cases, for adolescents experiencing allergy symptoms throughout the year, house dust mites may be the underlying allergy trigger," said 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 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.
A post hoc analysis of two pooled, double-blind, placebo-controlled trials conducted in North America and Japan, adolescents aged 12 to 17 years (N=395) with HDM allergic rhinitis were randomized to up to one year of treatment.4 The study found that ODACTRA reduced the average total combined rhinitis score (TCRS), the study's primary endpoint, by 22% compared to placebo (treatment difference of −1.04; P<.01).
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. The most common treatment-related adverse events (TRAEs) were local application site reactions.3 Most TRAEs were mild in intensity and were typically experienced the first one to two days of treatment.
"We are proud to now offer ODACTRA, a convenient allergy immunotherapy tablet that can be taken at home following an initial administration visit with a healthcare provider experienced in diagnosing and treating allergies, to adolescents in the United States. ODACTRA is a flexible solution that offers the opportunity for relief as teens and parents navigate their overscheduled lives," said Hans Lindeberg, senior vice president of ALK North America. "This milestone underscores our commitment to continue to bring innovative solutions to the millions of people who suffer from chronic allergies, especially to adolescents during their critical development years."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!