OREANDA-NEWS. Daiichi Sankyo Company, Limited, announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare to manufacture and market the osteoporosis treatment PRALIA® subcutaneous injection 60mg syringe (INN: Denosumab; genetic recombination) for the treatment of osteoporosis.

PRALIA® is a subcutaneous injection for use once every six months as a novel treatment for osteoporosis that specifically inhibits RANKL, an essential mediator for bone resorption. In a phase 3 clinical study on osteoporosis patients (DIRECT study) in Japan, PRALIA® significantly reduced the risk of new or worsening vertebral fracture compared to placebo. Additionally, no apparent difference in the risk of adverse events was found between PRALIA® and the placebo. PRALIA® was also well tolerated and effective in reducing the vertebral fracture risk in Japanese patients with osteoporosis.

Fractures resulting from osteoporosis can significantly lower the quality of life of osteoporosis sufferers, including elderly persons confined to bed. We anticipate that this new treatment for osteoporosis will contribute to better quality of life for patients while offering healthcare professionals a novel, new treatment option.