ANTONY, France I December 11, 2013 – STALLERGENES S.A. (Euronext Paris), world leader in sublingual immunotherapy, today announced that the Allergenic Products Advisory Committee (APAC) of the U.S. Food and Drug Administration (FDA) voted that the available data support approval of ORALAIR® for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children aged five and older.
ORALAIR® is a sublingual immunotherapy tablet that includes a five grass mixed pollens allergen extract from Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Grass allergies are the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. The five grass pollens included in ORALAIR® represent those to which most patients in the U.S. are exposed.
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).
Roberto Gradnik, Chief Executive Officer of STALLERGENES, said:”We are very pleased that the Advisory Committee has made a positive recommendation supporting the approval of ORALAIR® for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis. 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.”
In October, GREER and STALLERGENES announced the signing of an exclusive agreement for the United States commercialization rights to ORALAIR®. Under the terms of the agreement, GREER will lead the sales and marketing efforts for ORALAIR® in the United States and STALLERGENES will be responsible for tablet production and supply.
SOURCE: Stallergenes
Post Views: 248
ANTONY, France I December 11, 2013 – STALLERGENES S.A. (Euronext Paris), world leader in sublingual immunotherapy, today announced that the Allergenic Products Advisory Committee (APAC) of the U.S. Food and Drug Administration (FDA) voted that the available data support approval of ORALAIR® for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children aged five and older.
ORALAIR® is a sublingual immunotherapy tablet that includes a five grass mixed pollens allergen extract from Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Grass allergies are the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. The five grass pollens included in ORALAIR® represent those to which most patients in the U.S. are exposed.
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).
Roberto Gradnik, Chief Executive Officer of STALLERGENES, said:”We are very pleased that the Advisory Committee has made a positive recommendation supporting the approval of ORALAIR® for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis. 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.”
In October, GREER and STALLERGENES announced the signing of an exclusive agreement for the United States commercialization rights to ORALAIR®. Under the terms of the agreement, GREER will lead the sales and marketing efforts for ORALAIR® in the United States and STALLERGENES will be responsible for tablet production and supply.
SOURCE: Stallergenes
Post Views: 248
