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FDA NEWS RELEASE

For Immediate Release: April 2, 2014
Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov

 

FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies

The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care 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 allergic diseases affect approximately 30 million people in the United States and more than 500 million persons worldwide. These diseases are often caused by sensitivity to grass pollen. 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,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
 
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 health care 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 was evaluated in studies in the United States and Europe, involving approximately 2,500 people. Some patients received Oralair; others received an inactive substitute (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 percent reduction in symptoms and the need for medications compared to those who received a placebo.  
 
The prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) 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, as well as 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. 

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 04/02/2014
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