ALK’s ODACTRA gains FDA approval for pediatric house dust mite allergy treatment

The U.S. Food and Drug Administration (FDA) has expanded the approved use of ODACTRA house dust mite allergy immunotherapy, making it available for children aged 5 through 11 years. This regulatory milestone, announced by ALK, means younger children suffering from house dust mite allergy symptoms now have access to a scientifically backed treatment that offers long-term relief beyond traditional allergy medications.

House dust mites are among the most common triggers of allergic rhinitis in children, leading to persistent symptoms such as sneezing, nasal congestion, and itchy, watery eyes. Unlike antihistamines and nasal sprays that provide only temporary relief, ODACTRA house dust mite immunotherapy modifies the immune response, helping to build long-term tolerance. The expansion of its pediatric indication means parents now have an alternative to allergy shots, a treatment that many younger children find difficult to tolerate.

How does ODACTRA work to treat house dust mite allergies?

ODACTRA, developed by ALK, is the first FDA-approved sublingual immunotherapy for house dust mite allergies, designed to target the root cause of allergic reactions rather than simply managing symptoms. The tablet, which dissolves under the tongue, delivers controlled doses of house dust mite allergens to the immune system, gradually training the body to develop tolerance.

By regularly exposing the immune system to allergens in small amounts, ODACTRA house dust mite therapy can help desensitize the body’s response, reducing the severity of allergic reactions over time. This approach, known as allergy immunotherapy, is widely recognized as the only treatment that offers long-term relief by modifying the immune system’s behavior rather than just suppressing symptoms.

According to Jackie Eghrari-Sabet, an allergist and immunologist at the George Washington University School of Medicine, the approval of ODACTRA house dust mite immunotherapy for younger children is a crucial step forward. She explained that sublingual administration makes the treatment more accessible for pediatric patients while reducing their reliance on symptomatic medications like antihistamines and nasal steroids.

What clinical data supported the FDA’s decision?

The FDA’s expanded approval was based on a Phase 3 pediatric trial conducted by ALK, involving 1,458 children aged 5 through 11 years. This study is considered the largest clinical trial to date for house dust mite allergy in children receiving allergen immunotherapy.

The randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of ODACTRA house dust mite therapy over a one-year period. The primary endpoint measured the change in total combined rhinitis score (TCRS), a research metric that combines daily rhinitis symptoms with medication usage.

The study’s findings demonstrated that children receiving ODACTRA experienced a 22% reduction in TCRS compared to those in the placebo group. This reduction aligns with the clinical standards set by the World Allergy Organization, which defines a meaningful treatment effect as a 20% or greater improvement in symptom and medication scores.

Safety data from the trial indicated that ODACTRA was well tolerated, with a safety profile consistent with what has been observed in adolescents and adults. Most treatment-related adverse events were mild or moderate and included oral itching, throat irritation, and ear pruritus. Importantly, there were no reports of treatment-related anaphylaxis, serious adverse events, or emergency intervention requiring epinephrine in the pediatric group.

The study’s full results were published in The Lancet Regional Health – Europe, reinforcing the credibility of the trial and the scientific validity of ODACTRA’s expanded use.

How does ODACTRA compare to traditional allergy treatments?

For children with house dust mite allergy symptoms, treatment options typically include antihistamines, nasal corticosteroids, and allergy shots (subcutaneous immunotherapy). While these treatments can be effective in controlling symptoms, they often require frequent dosing or invasive administration.

ODACTRA house dust mite therapy, developed by ALK, offers a non-invasive, long-term solution that can be administered at home after the first dose is taken under a doctor’s supervision. Unlike allergy shots, which require regular visits to a healthcare provider, SLIT-tablets like ODACTRA offer a more convenient alternative while maintaining effectiveness.

Additionally, while antihistamines and nasal sprays provide short-term relief by blocking allergic reactions, ODACTRA house dust mite immunotherapy actively reshapes the immune system’s response to allergens, potentially offering benefits that last well beyond the treatment period.

What does this approval mean for ALK and the allergy immunotherapy market?

The FDA’s decision to expand ODACTRA house dust mite immunotherapy to younger children strengthens ALK’s position in the allergy treatment market. As a company with over a century of experience in allergy research and immunotherapy, ALK continues to expand its portfolio with evidence-based treatments for respiratory allergies.

Judit Nyirady, ALK’s Global Chief Medical Officer, emphasized that the expanded approval aligns with the company’s mission to provide innovative solutions for patients across all age groups. She noted that younger children who previously had limited options now have access to a treatment that can address the underlying cause of their allergies rather than merely managing symptoms.

The market impact of this approval is expected to be significant, as an increasing number of parents and physicians seek long-term allergy treatment options for children. With house dust mite allergy in children being a major contributor to pediatric allergic rhinitis, the availability of a non-invasive, at-home therapy could shift the standard approach to allergy management.

What are the next steps for ODACTRA and pediatric allergy treatment?

With the FDA’s expanded approval, ODACTRA house dust mite therapy is now positioned to become a first-line treatment option for pediatric allergic rhinitis. Physicians specializing in allergy and immunology are expected to incorporate ODACTRA into treatment plans, particularly for children who struggle with compliance using other allergy therapies.

As research into allergy immunotherapy continues, there is potential for further label expansions and new indications for ODACTRA house dust mite and other SLIT-tablets. Ongoing studies may explore additional patient populations, long-term outcomes, and the possibility of combining immunotherapy approaches for enhanced effectiveness.

For now, the FDA’s decision represents a meaningful advancement in allergy care, offering new hope for families seeking long-lasting relief from house dust mite allergy in children. As adoption of ODACTRA house dust mite therapy grows, the treatment could reshape the way pediatric allergic rhinitis is managed, providing children with a more effective and convenient alternative to traditional allergy medications.