US FDA approves Odactra sublingual treatment for dust mite allergy

Woman with hay fever

The US Food and Drug Administration (FDA) has approved the sublingual allergy immunotherapy tablet (SLIT) Odactra for the treatment of dust mite allergy. 

The once-daily tablet — marketed by Merck Sharp & Dohme and ALK — is indicated for use in adults aged between 18 and 65 years with confirmed house dust mite-induced allergic rhinitis, with or without conjunctivitis. 

The treatment was evaluated in placebo-controlled trials involving around 2,500 people. Patients assigned to Odactra had a 16–18% reduction in symptoms and the need for additional medications compared with those on placebo. 

The most common adverse reactions reported in clinical trials were nausea, itching in the ears and mouth, and swelling of the lips and tongue. 

The first dose has to be taken under supervision, owing to the risk of severe allergic reaction.

The FDA also says that all patients should be prescribed an EpiPen injection (contains adrenaline; known as epinephrine in the United States) alongside Odactra. The prescribing information will also carry a boxed warning on the risk of severe allergic reactions. 

SLIT therapy works by repeatedly exposing the patient to an allergen over time, in order to modify their immunological response. The FDA has previously approved three other SLIT therapies, including two for grass-pollen allergy and one for short-ragweed pollen allergy. 

Odactra, which is marketed as Acarizax in the EU, was approved for allergic rhinitis and allergic asthma under the European Medicines Agency decentralised procedure in 11 countries in August 2015. There are apparently no plans to market the product in the UK at present.

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Citation
The Pharmaceutical Journal, PJ, March 2017, Vol 298, No 7899;298(7899):DOI:10.1211/PJ.2017.20202408