Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture and market Ranmark SC injection 120mg (denosumab) to treat giant cell tumor of bone (GCTB).
Denosumab was designated as a pharmaceutical for the treatment of rare diseases by Japan’s Ministry of Health, Labor and Welfare in June 2013 for efficacy against GCTB. It is the world’s first fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation, the company said. Daiichi Sankyo has been working on denosumab since 2007, when it acquired the rights from US biotech group Amgen (Nasdaq: AMGN) to develop and market this antibody in Japan.
Other indications
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