This is big news for parents.
The U.S. Food and Drug Administration (FDA) has recently expanded the use of Odactra, a sublingual tablet designed to treat house dust mite-induced allergic rhinitis, to include children aged 5 to 11. This medication works as an allergy immunotherapy, helping to reduce allergy symptoms caused by dust mites. It is taken as a small tablet that dissolves under the tongue.
The expanded approval was based on results from a phase 3 clinical trial involving 1,460 children who had persistent allergic rhinitis symptoms for a year despite using other medications. In the study, children who received Odactra experienced a 22% greater reduction in their total combined rhinitis score compared to those who took a placebo. Some mild side effects, such as ear and mouth itching, a tingling sensation, and abdominal pain, were observed in a few children. However, there were no severe reactions like anaphylaxis or incidents that required epinephrine treatment.
Dr. Jackie Eghrari-Sabet, an allergist at George Washington University, emphasized the significance of this approval, as it gives both physicians and parents a new option for managing dust mite allergies in younger children. She also pointed out the added benefit of sublingual administration, which is more convenient than other methods of treatment.
The trial also noted that while some children experienced minor side effects, the overall safety profile was positive. The approval provides a potential new treatment for children who struggle with severe allergic rhinitis and have had limited success with other medications.
This expanded indication for Odactra offers a new tool in the management of allergic rhinitis in children, a common condition that often requires long-term care. The FDA’s approval could improve the quality of life for children with dust mite allergies by reducing their symptoms and reliance on other allergy medications.
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