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FDA approves Oralair, first SLIT agent for grass allergies
The FDA has approved the first sublingual oral immunotherapy tablet for grass allergies in the United States, according to a press release.
Oralair (sweet vernal, perennial rye, Orchard, Timothy and Kentucky blue grass mixed pollens allergen extract, Greer/Stallergenes) 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. 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.”
Karen Midthun
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 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.
For more information:
FDA Briefing Document. Biologic License Application (BLA) for Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use. Accessed April 2, 2014.
Perspective
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If we look at allergy patients about 1 out of 4 individuals have allergies and about half of those individuals have moderate-to-severe allergies; those are the patients that benefit from some form of treatment, other than the usual OTC medications available like antihistamines. If you look at just antihistamines in patients with more moderate-to-severe allergies, they are unlikely to adequately control the symptoms. Even in mild allergies, at best, you have 30% to 40% of partial relief of symptoms. Therefore, there are about 60% to 70% of allergy patients that need therapy beyond current medications available.
I like to diveide the treatment of allergies into three components; one is avoidance. Unfortunately, pollen is difficult to avoid, even with closing windows and using air conditioners. There’s still about 30% of the outdoor pollen levels getting indoors.
Second are medications and third allergen immunotherapy. Subcutaneous immunotherapy has been the only approved therapy and is very effective. The addition of the grass pollen tablets will be beneficial to selective patients who are only sensitized to grass pollen.
In addition, we often see patients who believe they have seasonal pollen allergies, but actually have mold allergies. The vast majority of our patients that we see, if you test are found to have multiple sensitivities, so I think the new treatment will offer an opportunity to educate patients about allergies, and certainly there will be some patients who benefit from the treatment. It also enables those same patients to seek advice and care from board-certified allergists.