FDA approves Oralair for Grass Pollen induced Allergic Rhinitis - Stallergenes + Greer Labs

Stallergenes, announced that the FDA 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. The approval of Oralair provides an additional treatment option for allergy specialists and their patients.

Grass allergy is the most common seasonal skin 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.

In October 2013, Greer Laboratories and Stallergenes announced the signing of an exclusive agreement for the U.S. commercialization rights to Oralair. Under the terms of the agreement, Greer will lead the sales and marketing efforts for Oralair in the United States and Stallergenes will be responsible for tablet production and supply.

Oralair was originally approved in Europe in 2008 and is currently authorized in 31 countries around the world, including most European countries, Canada, Australia, and Russia.