The Food and Drug Administration has approved a new indication for ALK’s under-the-tongue immunotherapy tablet Ragwitek (Ambrosia artemisiifolia) to treat ragweed pollen–induced hay fever in children aged 5-17 years.
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Ragwitek received FDA approval in 2014 to treat short ragweed pollen–induced hay fever, with or without allergic rhinoconjunctivitis, in adults aged 18-65 years.
The approval for Ragwitek comes with a boxed warning regarding a risk for life-threatening allergic reactions associated with the immunotherapy treatment, including anaphylaxis and severe laryngopharyngeal restriction. The package insert specifies that physicians should prescribe autoinjectable epinephrine with the drug.
“Ragwitek tablets provide a new immunotherapy treatment option for children and adolescents with seasonal ragweed allergies which often causes uncomfortable nasal symptoms and red, itchy eyes during the late summer and early fall,” David I. Bernstein, MD, University of Cincinnati, Bernstein Clinical Research, said in a company press release.
Short ragweed pollen is one of the most common weed allergies. Allergic rhinitis, or hay fever, affects 10%-30% of the population worldwide, according to the American Academy of Allergy Asthma & Immunology. In the United States, approximately 7.7% of adults and 7.2% of children were diagnosed with it annually, according to the Centers for Disease Control and Prevention.
The new indication was based partly on data from a phase 3 clinical trial in children with short ragweed–induced allergic rhinitis, or hay fever, published in the Journal of Allergy and Clinical Immunology. In the study, researchers evaluated the efficacy and safety of the treatment in 1,022 participants aged 5-17 years with a history of ragweed-induced rhinoconjunctivitis and sensitivity to ragweed over a 20- to 28-week treatment period.
Researchers found that Ragwitek improved symptoms in children and adolescents and decreased their use of symptom-relieving medication, compared with placebo.
Among children and adolescents aged 5-17 years, the most common adverse reactions reported were throat irritation/tickle (48.3% in the Ragwitek group vs. 17.7% in the placebo group), itching in the mouth (47.8% vs. 11.2%), itching in the ear (33.9% vs. 6.3%), mouth pain (18.9% vs. 4.5%), swelling of the lips (13.8% vs. 1.2%), nausea (11.5% vs. 3.3%), swelling of the tongue (11.3% vs. 0.8%), throat swelling (10.7% vs. 1.6%), and stomach pain (10.1% vs. 4.5%).
The FDA also recommends that Ragwitek not be prescribed to people with severe, unstable, or uncontrolled asthma, those with a history of severe systemic allergic reactions, and those with a history of eosinophilic esophagitis. The immunotherapy treatment also may not be suitable for people who are unresponsive to epinephrine or inhaled bronchodilators.
In addition, the treatment is not approved for the immediate relief of allergic symptoms in children or adults. The once-daily treatment, which contains an extract from short ragweed pollen, should begin 12 weeks before the start of ragweed pollen season and continue throughout the season, according to the FDA.
Dr. Bernstein said that the under-the-tongue immunotherapy works by targeting the specific allergy trigger and reducing allergy symptoms by “stimulating the immune system.”
A version of this article first appeared on Medscape.com.