News from the FDA/CDC

FDA approves sublingual immunotherapy for dust mite allergies


 

The Food and Drug administration has approved a sublingual immunotherapy to treat nasal inflammation caused by dust mite allergy.

The sublingual tablets are intended to be taken daily, year-round, and the first dose must be taken under physician supervision to monitor for adverse reactions, according to the FDA. As with other sublingual immunotherapies, patients using the tablets should be simultaneously prescribed autoinjectable epinephrine.

The approval was based on results from randomized trials enrolling about 2,500 patients in Europe and the United States, according to the FDA. Patients taking the tablets saw a 16%-18% reduction in symptoms across studies, compared with placebo. Clinical benefit may be delayed by 8-14 weeks after starting the therapy, the agency said. Common adverse reactions reported in the studies included nausea, itching of the ears and mouth, and swelling of the lips and tongue.

Odactra is the fourth sublingual immunotherapy to be approved in the United States since 2014. Other approved therapies target grass and ragweed allergies.

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