French biopharmaceutical company Poxel SA (Euronext:POXEL) reported on Thursday the submission of a Japanese New Drug Application (J-NDA) for its lead product, Imeglimin.
Poxel's Japanese partner, Sumitomo Dainippon Pharma, submitted the application to the Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
The Imeglimin J-NDA is supported by preclinical and clinical trials, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) project in Japan which included three pivotal trials to evaluate Imeglimin's efficacy and safety in over 1,100 patients. In all three trials, Imeglimin met its primary endpoints and objectives and was observed to exhibit a favourable safety and tolerability profile, the company said.
Thomas Kuhn, CEO of Poxel, said that the J-NDA submission represents a "significant milestone" for the company and the culmination of several years of clinical development work.
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