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Oralair, the first sublingual immunotherapy tablet for the treatment of grass pollen allergy approved by FDA


The FDA ( Food and Drug Administration ) has approved Oralair, the first immunotherapy tablet to be available in the U.S. for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.
Until now, allergen immunotherapy has been administered via a series of subcutaneous injections in the allergy specialist’s office.

Grass allergy is the most common seasonal allergy in the United States and most people are allergic to more than one type of grass.

Oralair contains a mix of five grass pollens: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. The five grass pollens contained in Oralair represent those to which most patients in the U.S. are exposed.

Oralair is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product.
Oralair is approved for use in persons 10 through 65 years of age.

Oralair is a tablet that dissolves under the tongue. The first dose is taken in the doctor’s office under medical supervision, and subsequent doses are administered once a day by the patient or the patient’s caregiver.
Oralair treatment should be started four months before the expected onset of each grass pollen season and continued throughout the season.
Allergy symptoms are reduced beginning with the first grass pollen season.

Oralair was originally approved in Europe in 2008.

Oralair has been approved based on results from an extensive clinical development program. Oralair has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in over 2,500 adults and children. The results of these trials have demonstrated that pre-seasonal and co-seasonal treatment reduces patients’ allergy symptoms and their need for symptom-relieving medication.
In the clinical development program, the most common adverse reactions for Oralair ( reported in greater than or equal to 5% of patients ) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. ( Xagena )

Source: Stallergenes, 2014

XagenaMedicine_2014



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