FDA Expands Odactra Approval To Treat House Dust Mite Allergies In Children

Odactra is an allergy immunotherapy designed to treat allergic rhinitis, also commonly known as hay fever. This is caused by house dust mites. Odactra comes in the form of small tablet that easily dissolves under the tongue, also called sublingual administration and helps the immune system to build tolerance to allergies over time.

With many things new in the US health section, the US Food and Drug Administration (FDA) has expanded the use of Odactra to include children aged 5 to 11 years. Previously, it was only approved for older patients. This expansion provides a new treatment option for the younger patients who are suffering from dust mite-induced allergic rhinitis, with or without conjunctivitis.

Clinical Trial and Its Findings

The FDA's approval came after the phase 3 trial that involved 1,460 children aged 5 to 11 who had persistent allergic rhinitis. Their symptoms were not relieved despite using medications. The key findings from the trial included:

• Children who received Odactra had 22% reduction in total combined rhinitis scores as compared to the children who received placebo
• 4 children experienced severe side effects, including oral and ear itchiness, burning or tingling sensation in the mouth, lip swelling, and abdominal pain
• There were no cases of anaphylaxis or adverse reactions requiring epinephrine were reported

Why Is This Approval So Important?

According to experts, this approval is an important step in the pediatric allergy treatment. Dr Jackie Eghrari-Sabet, who is an allergist and immunologist at George Washington University, told a media outlet that its convenient sublingual administration and its ability to reduce allergy symptoms and medication dependence make it a valuable option for the younger patients.

What Are Dust Mites?

One of the most prevalent pests in your bed is dust mites. We shed over 500 million skin cells every day, giving these minuscule beings an unlimited meal. Dust mites by themselves are not very dangerous, but their droppings can cause eczema, asthma, and allergies, especially in sensitive people. These microscopic intruders feed on the skin cells you lose during the night and flourish in the warmth of your mattress, pillows, and bedding.

Your Beds Are Not Safe

Additionally, bed linens offer dangerous bacteria the ideal environment for growth. According to a 2013 study from the Institut Pasteur de Lille in France, Staphylococcus germs, which are frequently found on human skin, were abundant in filthy hospital bed linens. Some Staphylococcus strains, such as S. aureus, can cause severe skin infections, acne, and even pneumonia, especially in patients with compromised immune systems, even though the majority are benign.

"People carry bacteria as part of their skin microbiome and can shed them in large numbers," says Manal Mohammed, a scientist at the University of Westminster. If these germs get into the body through open wounds, which is more likely to happen in hospitals where patients are more susceptible, they can become harmful. In fact, a 2018 study found that unclean hospital bed linens included E. coli and other dangerous germs that can lead to sepsis, pneumonia, meningitis, and urinary tract infections.

Researchers found in 2022 that when patients with monkeypox (now known as mpox) changed their bed sheets, they dispersed virus particles into the air, potentially increasing the chance of transmission. Certain bacteria cannot be completely eliminated, even by hospital protocols that guarantee linens are cleaned at extremely high temperatures.

Even at high temperatures, the bacterium that causes severe diarrhea, Clostridium difficile, or C. difficile, is difficult to eradicate. However, strict laundry procedures at medical facilities have reduced infection rates.