FDA Advisory Committee Supports Approval of ORALAIR® for the Treatment of Grass Pollen Allergy
GREER® Labs has announced that the Allergenic Products Advisory Committee (APAC) of the FDA voted that the available data support approval of the Biologic License Application (BLA) for ORALAIR ® for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species included in the product.
GREER holds exclusive U.S. commercialization rights to ORALAIR ® through its partnership with STALLERGENES, developer and manufacturer of the product.
ORALAIR ® is an investigational 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 grasses included in ORALAIR ®, if approved, would provide a wide range of grass allergy coverage in the United States.
The FDA advisory committee supports the approval of ORALAIR ® based on safety, efficacy and tolerability results from an extensive clinical development program which includes, in both the United States and Europe, over 2,500 adults and children. ORALAIR ® was generally well tolerated and the most common treatment-emergent adverse events (greater than 10%) were application site reactions including oral pruritus and throat irritation. The FDA will likely consider the recommendations from the FDA advisory committee in its review of ORALAIR ® but is not required to follow them.
“We are pleased with the Allergenic Products Advisory Committee’s positive vote for ORALAIR ®,” said John G. Roby, GREER president and CEO. “Based upon this milestone, our goal is to continue to work with our partner STALLERGENES to bring ORALAIR ® to patients in the United States as part of our dedication to advancing allergy immunotherapy.”
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 would be responsible for the sales and marketing efforts for ORALAIR ® in the United States and STALLERGENES would be responsible for the manufacturing and supply of the product.