Stallergenes filed with the FDA to sell a first-of-its-kind sublingual allergy medication in the U.S., furthering the company's ongoing international expansion.
The French company is seeking a Biologics License Agreement with U.S. authorities for its oral allergen immunotherapy, Oralair.
During allergen immunotherapy, a patient is dosed with a small amount of the allergic substance. By introducing allergens such as pollen or dust mites, the process is meant to rehabilitate the immune system and encourage long-term tolerance. The current standard of care for allergic rhinitis, a severe respiratory disease that affects 60 million people in the U.S., is for a medical professional to perform a series of injections.
But Stallergenes' tablet is taken under the tongue and contains 5 of the pollen extracts at the root of many allergies: Perennial Ryegrass, Kentucky Bluegrass, Timothy Grass, Orchard Grass and Sweet Vernal Grass. By forgoing the needle delivery, a patient can take the tablet at home.
Oralair is available in Europe, Australia, New Zealand, Russia and, as of a few months ago, Canada. Stallergenes has been extending its reach to several of these markets in the last few years, making international expansion a priority.
This isn't the first time Stallergenes has looked to gain traction in the U.S. Back in 2010, the company looked for American partners to ultimately market Oralair. Merck ($MRK) also looks to take a chunk of the market with its yet-unapproved allergy tablet Grazax.
- here's the release