HealthDay News — The FDA has approved Oralair, the first sublingual treatment for grass-pollen induced allergic rhinitis with or without conjunctivitis, for people aged 10 through 65 years.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
The tablet contains freeze-dried pollen extracts of five grasses: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy. The once-daily tablet is placed under the tongue where it rapidly dissolves, the agency said in a news release.
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The once-daily tablet is designed to be started four months before the allergy season begins. Clinicians should administer the first dose in the office, so patients can be observed for any serious reactions. After that, the product can be taken at home.
Some 30 million people in the United States and 500 million globally have been diagnosed with allergic rhinitis, according to the FDA.
Oralair’s safety and effectiveness were clinically evaluated in 2,500 people. During treatment for one grass pollen season, patients assigned to Oralair experienced a 16% to 30% reduction in symptoms and the need for medications compared to those who assigned to placebo.
The product’s label will include a boxed warning that people who are highly allergic to grass pollen may have a severe reaction, including life-threatening anaphylaxis. More common side effects reported were itchy ears and mouth, swelling of the mouth and throat irritation.
Oralair is produced by the French firm Stallergenes S.A. of Antony, France.
