Stallergenes' Oralair gains US FDA panel backing

France’s Stallergenes (Euronext Paris) said late yesterday that the Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration had voted that the available data support approval of Oralair, an investigational grass allergy immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children aged five and older.

The APAC supports approval of Oralair based on safety, efficacy and tolerability results from an extensive clinical development program which includes trials in both the United States and Europe in over 2,500 adults and children. The recommendations of the APAC are not binding, but will be considered by FDA as the agency completes its review of the Biologics License Application (BLA).

Welcoming the advisory panel recommendation, Roberto Gradnik, chief executive of Stallergenes, said: "We will continue to work with the FDA as it completes its assessment of the Oralair BLA. We are convinced that Oralair, the only five-grass allergy immunotherapy tablet to be potentially approved by FDA, will bring a true benefit to US patients suffering from grass pollen induced allergy.”