FDA Approves Odactra for House Dust Mite Allergies
Updated: Mar 3rd 2017
FRIDAY, March 3, 2017 (HealthDay News) -- A new treatment for dust mite allergies has been approved by the U.S. Food and Drug Administration.
Odactra is a year-round, once-a-day tablet that's taken sublingually to treat house dust mite-induced allergic rhinitis, with or without conjunctivitis. It's approved for use in people aged 18 to 65.
In clinical trials, patients who took Odactra had a 16 to 18 percent reduction in allergy symptoms requiring use of other medicine, compared to those who took an inactive placebo. The most common side effects were nausea, itching in the ears and mouth, and swelling of the lips and tongue. Odactra carries a boxed warning stating that severe, and potentially life-threatening, allergic reactions can occur.
"House dust mite allergic disease can negatively impact a person's quality of life," Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms."
Odactra is manufactured for Merck, Sharp & Dohme by Catalent Pharma Solutions.
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