Greer Labs gets FDA approval for Oralair

LENOIR, N.C. — Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.



Oralair is used for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. It's approved for people ages 10 years through 65 years.



Traditionally, allergy immunotherapy in the United States has been administered through a series of subcutaneous injections in an allergy specialist's office. The approval of Oralair provides an additional option for allergy specialists and patients to consider when treating grass allergies.



“We are very pleased with the FDA’s approval of Oralair and believe it will provide a valuable treatment alternative for many patients with grass allergies,” said John G. Roby, Greer president and CEO. “Until now there has not been a sublingual allergy immunotherapy tablet available for grass allergic patients. As part of our dedication to advancing allergy immunotherapy, we look forward to launching Oralair with our partner Stallergenes and bringing this treatment option to patients here in the United States."  



Grass allergies are the most common seasonal allergy in the United States. Oralair is the only FDA-approved oral allergy immunotherapy tablets that includes a five grass, mixed pollens allergen extract, the company said, which provides a wide range of grass allergy coverage. The Oralair tablet dissolves under the tongue; the first dose is taken in the doctor's office under medical supervision, with subsequent doses administered once a day by the patient or a caregiver.