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Stallergenes's Oralair - sublingual allergen extract gets approval from FDA

 

Clinical courses

 

Clinical courses

Recently, U.S. Food and Drug Administration approved Oralair, first sublingual allergen extract approved in the United States, to treat allergic rhinitis with or without conjunctivitis that is induced by certain grass pollens in age group of 10 to 65 years. 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.

First dose of Oralair is taken in presence of health care provider for observing potential adverse reactions and afterward it can taken at home. Oralair is a OD 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.

Allergic rhinitis with or without conjunctivitis are chronic diseases affecting children and adults. These allergic diseases affect approximately 30 million people in the US 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.

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.