The FDA has approved the first and only sublingual oral immunotherapy formulation, Oralair, a sublingual dissolving tablet for grass allergies in the United States.
Oralair (sweet vernal, perennial rye, Orchard, Timothy and Kentucky blue grass mixed pollens allergen extract, Greer/Stallergenes) is to be used as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin or blood testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. It is indicated for patients aged 10 to 65 years.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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.”
The first dose would be administered at a doctor’s office. Data indicate that the drug be initiated 4 months before the expected onset of each grass pollen season and continued throughout the season. In clinical trials, Oralair was well-tolerated; the most common adverse events were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. The drug contains a black boxed warning due to the drug’s potential for anaphylaxis and severe laryngopharyngeal edema. Oralair is contraindicated (not recommended) in patients with severe, unstable, or uncontrolled asthma, or with a history of severe systemic or local reaction to sublingual allergen immunotherapy.
Merck and Danish partner ALK Abelló also are expected to launch their rival agent, Grastek, later this year, according to a press release. Oralair was first approved in the European Union in 2008 and is marketed in Canada, Australia and Russia to treat grass pollen allergy.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "This is exciting as it represents the first FDA approved sublingual immunotherapy in the United States. While most studies have found that subcutaneous (injected) allergen immunotherapy is more effective than sublingual, this is an option for patients whose main allergen is grass pollen, and who desire a way to build their immunity to grass pollen without injections. While some practitioners in this country have offered sublingulair drop immunotherapy, this has generally been at doses far too low to have any clinical effect. These grass pollen tablets, while less effective than injections, should provide significant improvement in symptoms."