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Oralair becomes first approved sublingual allergen extract

Thursday April 3, 2014
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The Food and Drug Administration has approved the sublingual therapy Oralair to treat allergic rhinitis with or without conjunctivitis that is induced by certain grass pollens in people ages 10 through 65.

Oralair is the first sublingual allergen extract approved in the U.S. After administration of the first dose at a healthcare provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.

Allergic rhinitis with or without conjunctivitis are chronic diseases affecting children and adults. These diseases, which often are caused by sensitivity to grass pollen, affect approximately 30 million people in the U.S. and more than 500 million people worldwide. Affected people may suffer from repetitive sneezing, nasal itching, runny nose, nasal congestion and itchy and watery eyes.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “The approval of Oralair provides an alternative to allergy shots that must be given in a healthcare provider’s office.”

Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue. Oralair is started four months before the start of the grass pollen season and continued throughout the season. The first dose is taken at the healthcare provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions.

Oralair contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.

The safety and effectiveness of Oralair were evaluated in studies involving about 2,500 people in the U.S. and Europe. Study participants received either Oralair or a placebo. To assess the effectiveness, patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one grass pollen season, patients taking Oralair experienced a 16% to 30% reduction in symptoms and the need for medications compared with those who received a placebo.

The prescribing information includes a boxed warning that severe allergic reactions, including anaphylaxis, can occur. Oralair also has a medication guide for distribution to the patient. The most common adverse reactions reported by adults were itching in the ears and mouth and of the tongue, swelling of the mouth and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.

Oralair is manufactured by Stallergenes S.A. of Antony, France.

FDA committee information on Oralair: http://1.usa.gov/1gPvmDd


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