BETHESDA, MD 02 Apr 2014—FDA today announced its approval of a sublingual alternative to immunotherapy injections for people 10–65 years of age who are allergic to sweet vernalgrass, orchardgrass, perennial ryegrass, timothy, or Kentucky bluegrass.
Each tablet, the agency said, contains freeze-dried pollen extracts of those five perennial grasses.
The nonproprietary name of the biological is sweet vernal, orchard, perennial rye, Timothy, and Kentucky blue grass mixed pollens allergen extract.
Its manufacturer, Stallergenes S.A. of France, calls the biological Oralair.
FDA said the sublingual immunotherapy is to be taken once daily, with the patient receiving the first dose in the health care provider's office and remaining there under observation for at least 30 minutes.
Severe allergic reactions can occur during treatment with the biological, FDA said. A boxed warning in the biological's labeling alerts health care providers to this possibility, the agency said, and a medication guide informs patients.
Labeling for the product is not yet available online.
Therapy should begin four months before the start of the grass pollen season and continue until the season ends, FDA said.
Patients who took the sublingual immunotherapy for one grass pollen season during the clinical studies, the agency said, had fewer allergy symptoms and less need for medications than the patients who received a placebo.
FDA said the most common adverse reactions to the sublingual immunotherapy were swelling in the mouth and throat irritation. Adults, in addition, most commonly reported itching of their ears, mouth, and tongue.
Stallergenes has not announced when it will make Oralair available in the United States.
Greer Laboratories Inc., a North Carolina company that specializes in allergy immunotherapy products, said it has a partnership with Stallergenes to market Oralair in this country.
The North Carolina company said the biological is contraindicated in patients with severe, unstable, or uncontrolled asthma and patients who have had a severe systemic or local reaction to sublingual allergen immunotherapy.
Patients should be prescribed an epinephrine autoinjector, trained in its use, and told to seek immediate medical care after administering the product, the company said.