FDA approves Odactra for house dust mite allergy in adolescents

The FDA approved house dust mite allergen extract tablet for sublingual immunotherapy treatment of house dust mite-induced allergic rhinitis in patients aged 12 to 17 years, according to a press release from the manufacturer.

“Allergies interfere with a critical time of adolescent development when they undergo physical, cognitive, emotional and social changes,” Michael Blaiss, MD, clinical professor of pediatrics, division of allergy/immunology at the Medical College of Georgia at Augusta University, said in the release. “Odactra sublingual immunotherapy treats house dust mite allergy and can even help those polysensitized patients manage their symptoms.”

Michael Blaiss

House dust mite (Dermatophagoides farina and Dermatophagoides pteronyssinus) allergen extract tablet (Odactra, ALK) is indicated patients whose house dust mite-induced allergic rhinitis, with or without conjunctivitis, has been confirmed by in-vitro testing for IgE antibodies to these species of house dust mites or via skin testing to licensed house dust mite allergen extracts. It is not indicated for the immediate relief of allergic symptoms.

The approval is based on results from a 28-day, phase 3 trial and from a post-hoc analysis of two pooled, double-blind placebo-controlled trials. Each trial only involved adolescents aged 12 to 17 years. FDA previously approved the therapy for patients aged 18 to 65 years in 2017.

In the MT-18 phase 3 trial of 253 adolescents with house dust mite allergic rhinitis with or without conjunctivitis and with or without mild asthma, 88% experienced at least one treatment-emergent adverse event. The researchers said these results confirmed previous trials indicating that the tablet was well tolerated among adolescents.

The post-hoc analysis of 395 adolescents involved up to 1 year of treatment and found that the tablet reduced average total combined rhinitis scores by 22% compared with placebo (absolute treatment difference, –1.04; P < .01).

According to ALK, Odactra’s safety profile in children and adolescents was consistent with its safety profile for adults, with no treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema or eosinophilic esophagitis during the trials.

Local reactions at the application site were the most common treatment-related adverse events, and most of them were mild and typically experienced in the first 2 days of treatment, according to the release.

References:

• Matsuoka T, et al. Ped Allergy Immunol. 2017;doi:10.1111/pai.12747.
• Nolte H, et al. Poster P042. Presented at: ACAAI Annual Scientific Meeting; Nov. 10-14, 2022; Louisville, Ky.