21 February 2018 - - London, England-based biopharmaceutical company Stallergenes Greer (Paris: STAGR) Japanese partner Shionogi and Co. Ltd. has received approval for the extension of the indication for Actair, an allergy immunotherapy sublingual tablet for the treatment of house dust mite (HDM) induced allergic rhinitis, to treat patients under the age of 12, the company said.
Actair is already approved for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older in Japan.
The new drug application submission was supported by data from Shionogi's positive multi-center, randomized, double-blind, placebo-controlled Phase III trial that evaluated the efficacy of Actair at a daily maintenance dose of 300IR administered for 12 months to children between five and 16 years old with HDM-associated allergic rhinitis.
The active group demonstrated a statistically significant difference (p=0.0005) versus placebo on the Average Adjusted Symptom Score after one year of treatment, achieving the primary efficacy endpoint.
Stallergenes Greer has exclusive partnership agreements with Shionogi for the clinical development, registration and commercialization of HDM and Japanese cedar pollen sublingual immunotherapy tablets in Japan.
Stallergenes Greer is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. It is the parent company of GREER Laboratories, Inc. in the US and Stallergenes SAS in France.