FDA approves extension of approval of Oralair in grass allergy.- Stallergenes Greer.

Stallergenes Greer announced that it has received approval from the FDA for the extension of the indication for Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract), an allergy immunotherapy sublingual tablet, to treat patients ages five to nine with grass pollen-induced allergic rhinitis.

Oralair is the only allergy immunotherapy tablet that contains grass pollens from five of the most common grasses in the United States and received FDA approval in patients ages ten to 65 in 2014.

To support administration of Oralair in the pediatric population, an open-label study was conducted to evaluate the 30-day safety profile of Oralair in 307 children five through nine years of age. Adverse reactions reported at an incidence of at least 2% were: throat irritation (22.1%), oral pruritus (11.7%), oral paresthesia (11.1%), tongue pruritus (8.1%), mouth edema (6.2%), cough (6.2%), oropharyngeal pain (4.2%), ear pruritus (5.2%), eye pruritus (4.6%), lip edema (3.3%), vomiting (2.6%), tongue edema (2.3%), abdominal pain (2.3%), oral discomfort (2.3%), and ocular hyperemia (2.0%).