Global pharmaceutical company, Daiichi Sankyo Company Limited, announced that phase 3 clinical trials for AMG 162 (denosumab), a gene recombinant drug for patients with rheumatoid arthritis, has achieved a major objective.

The study conducted in Japan consisted of randomized, double-blind, placebo-controlled phase 3 clinical trials in patients with rheumatoid arthritis with disease-modifying anti-rheumatic drugs (DMARDs). In this study, denosumab showed excellent effects in preventing structural joint damage.

Daiichi Sankyo anticipates this new treatment for patients with rheumatoid arthritis will contribute to better quality of life for patients while offering healthcare professionals a novel treatment option.

Denosumab is the world’s first fully human monoclonal antibody to target RANK Ligand (RANKL), an essential mediator of osteoclast formation, function and survival approved for therapeutic use. Daiichi Sankyo has been working on denosumab since 2007, when it licensed the rights from Amgen Inc. to develop and market this antibody in Japan. Sales of a 60 mg preparation began in June 2013 as a therapeutic agent for osteoporosis under the product name, Pralia subcutaneous injection 60mg syringe. Sales of a 120 mg preparation as a treatment for bone complications stemming from multiple myeloma and bone metastases from solid tumours (Ranmark subcutaneous injection 120 mg) began in Japan in April 2012. In addition, in May 2014 we received approval in Japan for partial modification to Ranmark (subcutaneous injection 120 mg) to treat giant cell tumour of bone (GCTB). We are also currently participating global phase 3 clinical trials for breast cancer and adjuvant therapy (long-term administration study of non-blind phase) in Japan and promoting domestic phase 3 clinical trials for rheumatoid arthritis (extension phase).