FDA approves ORALAIR sublingual allergy immunotherapy tablet

Apr 2 2014

GREER^® Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, today announced that the U.S. Food and Drug Administration (FDA) has approved ORALAIR^® (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet. 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 grass pollen-specific IgE antibodies for any of the five grass species contained in the product. ORALAIR^® is approved for use in persons 10 through 65 years of age.

Allergy immunotherapy in the United States has traditionally been administered via a series of subcutaneous injections in the allergy specialist's office. The approval of ORALAIR^® provides an additional option for allergy specialists and patients to consider for treating grass allergies.

Grass allergies are the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. ORALAIR^® is the only FDA approved oral allergy immunotherapy tablet that includes a five grass, mixed pollens allergen extract. These five grasses provide a wide range of grass allergy coverage in the United States.

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^® should be started four months before the expected onset of each grass pollen season and treatment continued throughout the season. ORALAIR^® may reduce grass allergy symptoms for patients within the first allergy season that it is taken.

The ORALAIR^® clinical program was based on safety, efficacy and tolerability results from an extensive set of clinical trials which included, in both the United States and Europe, over 2,500 adults and children. ORALAIR^® was generally well tolerated and the most common adverse events (reported in ≥5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. Please see below for Important Safety Information, including content from the Boxed Warning.

GREER holds exclusive U.S. commercialization rights to ORALAIR^® through its partnership with STALLERGENES, developer and manufacturer of the product.

"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 U.S."