FDA OKs Dust Mite Allergy Drug for Young Kids

The FDA expanded the approval of a sublingual immunotherapy (SLIT; Odactra) for treating house dust mite allergies in young children, drugmaker ALK announced.

Taken as a once-daily tablet, the SLIT product is now indicated for treating dust mite-related allergic rhinitis, with or without conjunctivitis, in children ages 5 to 11 years. The drug, which contains a dust mite allergen extract, was initially approved in 2017 for adults up to age 65 and later in adolescents ages 12 to 17.

Of note, patients must be monitored for 30 minutes following the initial dose due to the risk of anaphylaxis, and the product is contraindicated in people with severe or uncontrolled asthma, as noted in a boxed warning.

Evidence supporting the label expansion to kids ages 5 to 11 came from a large randomized trial involving nearly 1,500 participants in North America and Europe. The phase III study met its primary endpoint, with the SLIT demonstrating a significant 22% reduction versus placebo in total combined rhinitis score over the final 8 weeks of the trial’s roughly 1-year treatment period.

Significant improvements in multiple key secondary outcomes related to symptoms and medication use were also met. Treatment improved disease-related quality of life, asthma symptoms, and also led to reductions in the use of asthma medications.

According to the labeling, common (≥10%) solicited adverse events (AEs) in the trial included itching in the mouth and ear, throat irritation, mouth ulcers, stomach and tongue pain, dysgeusia, nausea, and swelling of the lips, tongue, and in the back of the mouth. Treatment-related AEs were higher than with placebo, though most were mild or moderate in severity. Only 2.5% of patients discontinued the product due to toxicity.

Other boxed warnings note that epinephrine should be prescribed (along with appropriate training for parents/guardians), and that the drug may not be appropriate for patients with comorbidities that would reduce their chance of surviving a severe reaction or who might fail to respond to epinephrine or inhaled bronchodilators.

The drug is contraindicated in people with a history of severe systemic or local allergic reactions to SLIT allergen products and in patients with a history of eosinophilic esophagitis.

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