New Relief for Kids: FDA Greenlights ODACTRA® for Dust Mite Allergies

March 6, 2025

Raziya Begum

The U.S. Food and Drug Administration (FDA) has approved the ODACTRA® tablet for treating house dust mite (HDM) allergies in young children. This tablet is manufactured by ALK-Abelló A/S (ALK), a pharmaceutical company based in Denmark. Its earlier approval for patients aged 12 to 65 has been expanded to include children aged 5 to 11 who have HDM-induced allergic rhinitis, with or without conjunctivitis.

ODACTRA is an allergy immunotherapy (AIT) tablet taken sublingually, dissolving beneath the tongue. This administration method is significant for young children who may have difficulty with other allergic treatment options, such as swallowing tablets or receiving regular subcutaneous injections. This tablet provides long-term symptom relief by focusing on the allergic trigger affecting the immune system’s overreaction.

The expanded approval was based on findings from a double-blind, randomized, placebo-controlled, 1-year, Phase 3 clinical trial (NCT04145219). This study assessed the efficacy and safety of ODACTRA in younger children (5-11 years) with HDM-induced allergic rhinitis or rhino conjunctivitis with or without asthma (MT-12).

A total of 1460 patients (mean age = 8 ± 1.9 years) were randomized into sublingual ODACTRA (n = 729, male = 66.9%, White = 99.3%) group and placebo group (n = 731, male = 65.3%, White = 97.7%). All these patients were recruited from North America and Europe (95 sites). It is recommended that this medication be taken once per day. Patients with a history of non-HDM allergies and systemic allergic reactions were excluded.

The primary endpoint was the total combined rhinitis score (TCRS) assessed during the final eight weeks of the one-year treatment period. Secondary endpoints were the rhinoconjunctivitis total combined score (TCS), the daily medication score (DMS), the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score, and the rhinitis daily symptom score (DSS).

A statistically significant difference of 1.0 (95% confidence interval [CI]: 0.5, 1.4) was observed in TCRS scores between the ODACTRA group and placebo group with P < 0.0001. This resulted in a relative decrease of around 22% (95% CI: 12.0, 31.1). Similarly, statistical differences were observed in all secondary outcomes such as DMS (absolute difference = 0.5 [95% CI: 0.0, 0.9]; P = 0.03), rhinoconjunctivitis TCS (absolute difference = 1.0 [95% CI: 0.2, 1.7]; P = 0.01) and DSS (absolute difference = 0.3 [95% CI: 0.1, 0.6]; P = 0.02).

Overall, a significant reduction in treatment (>22%) and PRQLQ was observed in the ODACTRA group compared to the placebo group. This indicated a better quality of life for patients treated with ODACTRA compared to placebo subjects.

A higher incidence of adverse events (AEs) occurred in the ODACTRA group compared to the placebo group. The most frequent treatment-related AEs ranged from mild to high severity, and 2.5% of subjects discontinued the treatment due to AEs. Adverse events reported among ODACTRA patients included lip swelling, abdominal pain, ear and oral pruritus, and glossodynia.

This ALK’s HDM tablet is marketed under different brand names worldwide: in the USA as ODACTRA®, in Europe as ACARIZAX®, in India as Sensimune™, and in Japan as MITICURE™. This tablet has so far received approval for use in younger children in Europe and Japan.

“With this approval, younger children and older individuals with HDM allergy symptoms can now receive the treatment with ODACTRA sublingual tablets after this expanded approval in the U.S.,” said Judit Nyirady, Global chief marketing officer, ALK.

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