FDA approves Odactra for treating pediatric house dust mite-induced allergic rhinitis

The US Food and Drug Administration has approved Odactra (House Dust Mite Allergen Extract; ALK) tablet for treating pediatric patients aged 12 to 17 years with house dust mite (HDM)-induced allergic rhinitis.

Odactra has been confirmed through in vitro testing, making it approved as immunotherapy for HDM-induced allergic rhinitis both with and without conjunctivitis in individuals aged 12 to 65 years. The expanded indication was granted after several studies indicated safety and efficacy.

"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.

House mite allergies can lead to sneezing, runny or itchy nose, stuffy or congested nose, and itchy and watery eyes. Odactra is taken sublingually for treating house mite allergies.

In the MT-18 trial, the safety of Odactra was analyzed in European adolescents aged 12 to 17 years with HDM-induced allergic rhinitis. Patients with conjunctivitis, without conjunctivitis, with mild asthma, and without mild asthma were examined. 

The primary endpoint of the trial was at least 1 treatment-emergent adverse event, which was seen in 88% of patients. Data from the trial was consistent with North American and Japanese trials, showing well-tolerance in adolescents.

A post hoc analysis of 2 pooled, double-blind, placebo-controlled trials indicated a reduced mean total combined rhinitis score by 22% more in patients given Odactra than those given placebo.

Children and adolescents have presented with a similar safety profile when taking Odactra as adults. The most common adverse reactions included local application site reactions and were mostly mild in intensity and lasted for 1 or 2 days following treatment.

Severe allergic reactions from Odactra which require immediate medical care include trouble breathing, tight or swollen throat, trouble speaking or swallowing, dizziness or fainting, rapid or weak heartbeat, severe stomach cramps, vomiting, diarrhea, and severe skin itching or flushing.

Reference

U.S. FDA approves ALK's ODACTRA (House Dust Mite Allergen Extract) tablet for sublingual use as immunotherapy for adolescents. ALK INC. January 25, 2023. Accessed January 25, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-alks-odactra-house-dust-mite-allergen-extract-tablet-for-sublingual-use-as-immunotherapy-for-adolescents-301729972.html