Oralair The First FDA-Approved Hay Fever Immunotherapy Tablet

The U.S. Food and Drug Administration (FDA) has announced its approval of ORALAIR for the treatment of allergic rhinitis (hay fever) with or without conjunctivitis induced by certain grass pollen in patients 10 through 65 years old. Oralair, manufactured by Stallergenes, is the first approved sublingual allergen extract for the treatment of certain grass pollen allergies in the U.S.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, 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.”

Grass allergy is the most common seasonal allergy in the US. As most people are allergic to more than one type of grass, ORALAIR is formulated to contain five grass pollens to which most patients in the U.S. are exposed to: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment with ORALAIR should be initiated four months before the onset of the grass pollen season and continued throughout the season.

Christian Chavy, newly appointed CEO of STALLERGENES, said, “We are very pleased with the U.S. approval of ORALAIR, as it will bring a true benefit to US patients suffering from grass pollen-induced allergy. This approval is a major milestone for Stallergenes. The company not only developed ORALAIR but it also continues to expand the frontiers of allergen immunotherapy. I would like to congratulate my predecessor, Roberto Gradnik and his teams on this major achievement.”

Safety and efficacy of ORALAIR was assessed in studies conducted in the U.S. and the EU involving an estimated 2,500 people. Patients who were tested over one grass pollen season and who received ORALAIR experienced a reduction of symptoms and need for medication by 16 percent to 30 percent compared to placebo.

“We look forward to launching ORALAIR with our partner, GREER, a leader in the U.S. allergen immunotherapy market with strong and long-standing relationships with allergy specialists. Thanks to ORALAIR, U.S. allergy specialists will now be able to offer a valuable treatment alternative to their patients with grass pollen-induced allergy, including those likely to refuse or prematurely discontinue subcutaneous immunotherapy,” concluded CEO Chavy.