FDA Approves Stallergene's Oralair For Grass Pollen Allergy
By Cyndi Root
Stallergenes announced in a press release that the Food and Drug Administration (FDA) has approved Oralair. The immunotherapy treatment is indicated for people 10 to 65 years of age with grass pollen-induced allergic rhinitis with or without conjunctivitis. Christian Chavy, CEO of Stallergenes said,
“We look forward to launching Oralair with our partner, Greer, a leader in the U.S. allergen immunotherapy market with strong and long-standing relationships with allergy specialists.”
Oralair
Oralair treats patients with allergies to five kinds of grass: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Approved for people between the ages of 10 and 65 years of age, Oralair is administered sublingually, a tablet that dissolves under the tongue. Karen Midthun, 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.” A physician administers the first dose in the medical office about four months before the allergy season. Patients self-administer subsequent doses at home throughout the grass pollen season.
The FDA approved the new allergy drug based on clinical trials with over 2,500 adults and children. Studies showed that Oralair treatment was effective in reducing allergy symptoms. Common side effects include throat irritation, mouth edema, and oropharyngeal pain.
Stallergenes and Greer
Stallergenes and Greer signed an agreement in October of 2013 to market Oralair in the U.S. Stallergenes will manufacture the drug and Greer will market it. The FDA’s approval requires Greer to pay Stallergenes $10 million. Additionally, Greer is to remit payment for other regulatory approvals, commercial milestones, and royalties. Currently, Oralair is approved in 31 countries, including most European countries, Australia, Russia, and Canada. Over 110,000 patients have received 20 million doses of Oralair.