The Food and Drug Administration (FDA) has approved the use of Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract; Stallergenes Greer) for the treatment of grass pollen-induced allergic rhinitis in pediatric patients aged 5–9. Previously, this allergy immunotherapy (AIT) was indicated for patients 10–65 years old.
Specifically, 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 5 grass species contained in this product. The pediatric approval was based on a study involving 278 children and adolescents 5–17 years of age; patients received Oralair or placebo starting approximately 4 months prior to the grass-pollen season and continued treatment for the duration of the pollen season.
Efficacy was assessed via the daily recording of symptoms and rescue medication use with the Combined Score (CS), the Rhinoconjunctivitis Total Symptom Score (RTSS), and the Rescue Medication Score (RMS). Results showed a relative difference between Oralair and the placebo arm of:
- −30.1% (95% CI, −46.9; −13.2) for CS
- −30.6% (95% CI, −47.0; −14.1) for RTSS
- −29.5% (95% CI, −50.9; −8.0) for RMS
In addition, an open-label study was conducted to evaluate the 30-day safety profile of Oralair in 307 children 5 through 9 years of age. Adverse reactions reported at an incidence of ≥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%).
“We are very pleased to be able to make this effective and convenient treatment option with a demonstrated safety profile available for children ages 5 and over as well as adults,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “Oralair provides an important option to patients who seek the relief of AIT but want the convenience of taking a tablet at home.”
Oralair is available as a sublingual tablet equivalent to 100 IR (index of reactivity) and 300 IR of 5 grass mixed pollens allergen extract.
For more information visit Stallergenesgreer.com.