Stallergenes Greer, a biopharmaceutical company specializing in treatments for respiratory allergies, announced that its partner in Japan, Shionogi & Co. Ltd., 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. ACTAIR is already approved for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older in Japan since March 2015.

“The approval of ACTAIR for pediatric use in Japan will provide a valuable treatment option for patients under the age of 12 suffering from allergic rhinitis caused by an allergy to house dust mites. We are very pleased that this product will be available to even more patients in Japan,” said Fereydoun Firouz, chairman and CEO of Stallergenes Greer.

The New Drug Application submission was supported by data from Shionogi’s positive Phase III trial, which was announced in January 2017. The multi-center, randomized, double-blind, placebo-controlled studyevaluated the efficacy of ACTAIR at a daily maintenance dose of 300IR administered for 12 months to children between 5 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 Scoreafter one year of treatment, achieving the primary efficacy end point. In addition to Japan, Stallergenes Greer’s HDM tablet is registered in Australia, New Zealand and SouthKorea under the brand name ACTAIR for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older. Stallergenes has exclusive partnership agreements with Shionogi for the clinical development, registration and commercialization of HDM and Japanese cedar pollen sublingual immunotherapy tablets in Japan.

The primary endpoint was the AAdSS over the last month of the one-year treatment period. The AAdSS is the average of the total score of four rhinitis symptoms (sneezing, rhinorrhea, nasal congestion and nasalpruritus) adjusted for rescue medication use. This was a multi-center, randomized, double-blind, placebocontrolled study to assess the efficacy of HDM sublingual immunotherapy tablets for the treatment of allergicrhinitis. Patients aged 5 to 16 years old with medical history consistent with HDM-induced allergic rhinitiswere eligible. A total of 438 patients were randomized to receive 12 months of treatment with HDM sublingual immunotherapy tablets or placebo. The active group showed statistically significant difference(p=0.0005) compared to placebo. Local adverse reactions were observed, with most of them mild in nature with no marked safety concerns.