The US Food and Drug Administration’s (FDA) Allergenic Products Advisory Committee (APAC) has supported the approval of Greer Laboratories’ partner Stallergenes in its biologic licence application (BLA) for Oralair to treat grass pollen-induced allergic rhinitis or conjunctivitis.
Patients’ conditions are 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.
The investigational sublingual immunotherapy tablet Oralair includes a five grass mixed pollens allergen extract from Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass.
The company holds exclusive US commercialisation rights of Oralair through its partnership with European biopharmaceutical firm Stallergenes that develops and manufactures the tablet.
In the US, grass allergies are the most common seasonal allergy, with most people allergic to more than one type.
If approved, the five grasses included in the tablet would offer a wide range of grass allergy coverage in the US.
Advisory committee support is based on safety, efficacy and tolerability results from an extensive clinical development programme carried out in both the US and Europe in more than 2,500 adults and children.
Oralair was also generally well tolerated and the most common treatment-emergent adverse events were application site reactions including oral pruritus and throat irritation.
The FDA will likely consider the recommendations from its advisory committee in its review of Oralair but may not necessary follow them.
Greer president and CEO John Roby said: "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 2013, Greer and Stallergenes entered into an exclusive agreement for the US commercialisation rights to Oralair, under which Greer was responsible for the sales and marketing efforts for the drug in the US and Stallergenes would oversee the manufacturing and supply of the product.
Originally approved in Europe in 2008, Oralair is currently authorised in 29 countries around the world, including most European countries, Canada, Australia, and Russia for the treatment of grass pollen allergy.
Image: Pollen grains from a variety of common plants can cause hayfever. Photo: courtesy of William Crochot, Medium69.