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Daiichi Sankyo Receives Approval 25 mar 2013, in Japan for Manufacture and Marketing of PRALIA ® for the osteoporosis treatment PRALIA ®subcutaneous injection 60mg syringe (INN: Denosumab; genetic recombination) for the treatment of osteoporosis.
Denosumab is a fully human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, rheumatoid arthritis, multiple myeloma, and giant cell tumor of bone. It was developed by the biotechnology company Amgen.
Denosumab is designed to inhibit RANKL (RANK ligand), a protein that acts as the primary signal for bone removal. In many bone loss conditions, RANKL overwhelms the body’s natural defenses against bone destruction.
In June 2010, denosumab was approved by the U.S. Food and Drug Administration (FDA) for use in postmenopausal women with risk of osteoporosis under the trade name Prolia, and in November 2010, as Xgeva, for the prevention of skeleton-related events in patients with bone metastases from solid tumors. Denosumab is the first RANKL inhibitor to be approved by the FDA. In the summer of 2011 clinical trials were investigating denosumab in giant cell tumors, multiple myeloma with bone metastases, and hypercalcemia of malignancy, and further investigating its dosing and safety.
- Pageau, Steven C. (2009). “Denosumab”. MAbs 1 (3): 210–215. doi:10.4161/mabs.1.3.8592. PMC 2726593.PMID 20065634.
- McClung, Michael R.; Lewiecki, E. Michael; Cohen, Stanley B.; Bolognese, Michael A.; Woodson, Grattan C.; Moffett, Alfred H.; Peacock, Munro; Miller, Paul D. et al. (2006). “Denosumab in Postmenopausal Women with Low Bone Mineral Density”. New England Journal of Medicine 354 (8): 821–31. doi:10.1056/NEJMoa044459. PMID 16495394.
- Ellis, G. K.; Bone, H. G.; Chlebowski, R.; Paul, D.; Spadafora, S.; Smith, J.; Fan, M.; Jun, S. (2008). “Randomized Trial of Denosumab in Patients Receiving Adjuvant Aromatase Inhibitors for Nonmetastatic Breast Cancer”. Journal of Clinical Oncology 26 (30): 4875–82. doi:10.1200/JCO.2008.16.3832.PMID 18725648.
- “Prolia (denosumab)”. Products. Amgen. Retrieved 6 May 2012.
- Matthew Perrone (June 2, 2010). “FDA clears Amgen’s bone-strengthening drug Prolia”. BioScience Technology.
- “Amgen’s Denosumab Cleared by FDA for Second Indication”. 19 Nov 2010.
- “FDA Approves Denosumab for Osteoporosis”. 2 June 2010.
- Russell S. Crawford, BPharm; Morgane C. Diven, PharmD; Laura Yarbro, PharmD (2011). “Denosumab: A Review of Its Pharmacology and Clinical Implications”. Contemporary Oncology 3 (1).
MHLW, sNDA, JAPAN, Daiichi Sankyo has received approval for Anticancer Agent irinotecan hydrochloride hydrate
Irinotecan (Camptosar, Pfizer; Campto, Yakult Honsha) is a drug used for the treatment of cancer.
Irinotecan prevents DNA from unwinding by inhibition of topoisomerase 1. In chemical terms, it is a semisynthetic analogue of the natural alkaloid camptothecin.
Its main use is in colon cancer, in particular, in combination with other chemotherapy agents. This includes the regimen FOLFIRI, which consists of infusional 5-fluorouracil,leucovorin, and irinotecan.
Irinotecan received accelerated approval by the U.S. Food and Drug Administration (FDA) in 1996 and full approval in 1998. During development, it was known as CPT-11.