FDA approves Odactra to treat house dust mite allergies

The FDA has approved Odactra, the first allergen extract to be administered sublingually to treat allergic rhinitis with or without conjunctivitis induced by house dust mites, in people aged 18 through 65 years, according to a recent press release.

“House dust mite allergic disease can negatively impact a person’s quality of life,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release. “The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms.”

Dust mites can cause coughing, runny nose, nasal itching, nasal congestion, sneezing, and itchy and watery eyes in individuals with allergies. To reduce the frequency and severity of house dust mite-induced allergy symptoms, Odactra (Merck, Sharp & Dohme Corp.), a tablet that dissolves under the tongue, is taken once-daily, everyday, and gradually trains the immune system through exposure to house dust mite allergens. After the first dose is administered to the patient by a health care professional with experience in the diagnosis and treatment of allergic diseases and they are observed for at least 30 minutes for adverse reactions, patients can then take the medication at home.

Researchers conducted studies in the United States, Canada and Europe to evaluate the safety and efficacy of Odactra. Approximately 2,500 participants were randomized to receive Odactra or an oral placebo. Participants reported their symptoms and the need to use symptom-relieving allergy medications during the study period. Compared with participants who received placebo, those taking Odactra experienced a 16% to 18% reduction in symptoms and the need for extra medication.

Common adverse reactions included nausea, itching in the ears and mouth, and swelling of the lips and tongue. Severe allergic reactions may occur, and patients receiving this sublingual drug should be prescribed auto-injectable epinephrine, as recommended by the FDA.

Disclosure: Odactra is manufactured for Merck, Sharp & Dohme Corp. by Catalent Pharma Solutions Limited, United Kingdom.