First Sublingual Allergen Extract Approved for Hay Fever

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ANTONY, FRANCE – The first sublingual allergen extract for the treatment of certain grass pollen allergies has been approved by the Food and Drug Administration.

Oralair, manufactured by Stallergenes S.A. of Antony, France, was approved to treat allergic rhinitis with or without conjunctivitis caused by certain grass pollens in people ages 10 through 65 years.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, MD, 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 healthcare provider’s office. Oralair can be taken at home after the first administration.”

Oralair, a once-daily tablet that rapidly dissolves after it is placed under the tongue, 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.

The compound 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 a placebo. During treatment for one grass pollen season, patients taking Oralair experienced a 16% to 30% reduction in symptoms and the need for medications compared to those who received a placebo, according to the FDA.

A boxed warning included in prescribing information cautions that severe allergic reactions, including anaphylaxis, can occur with Oralair, which 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.

 

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