Stallergenes has been granted approval in Europe to market Oralair, a powerful new immunotherapy tablet for patients with severe rhinoconjunctivitis caused by grass pollens.
The treatment, which was first marketed in Germany for patients whose hay fever is inadequately controlled using symptomatic treatments such as antihistamines and corticosteroids, will now be available across the EU.
Stallergenes chairman and CEO Albert Saporta said that this registration confirms the evolution of immunotherapy towards EBM-documented, well-tolerated treatments, effective from the very first season.
"Immunotherapy tablets now share the same level of recognition as conventional pharmaceuticals and form a new therapeutic class: allergens," Saporta said.
Oralair is produced using an active substance made from the set of pollens patients are most likely to be exposed to in Europe. These include perennial rye grass, meadow grass, timothy grass, cocksfoot and sweet vernal grass.
The treatment is taken for four months prior to the pollen season and then throughout it, for three consecutive seasons.
Oralair is still undergoing a clinical development programme. The results of three Phase III clinical studies are expected by the end of 2009. Oralair was established as effective during a previous pharmacodynamic study.