欧盟批准安进denosumab上市
2010年5月28日，安进公司（Amgen）表示欧盟委员会已批准denosumab（Prolia）上市用于绝经后妇女骨质疏松症以及前列腺癌患者激素抑制相关骨丢失的治疗，以降低患者骨折的风险。本品已在欧盟27个成员国以及挪威、冰岛、列支敦士登获得批准。这是本品在全球范围内获得的首个上市许可。

本品为全人单克隆抗体，具有独特的作用机制，是第一个和唯一获批的特异性靶向RANK配体的药物。
本品的新药申请包含6项Ⅲ期临床研究数据。其中两项关键性Ⅲ期研究评价了本品在骨质疏松症和前列腺癌患者中降低骨折风险的疗效。结果显示，每六个月给予本品60 mg皮下注射降低骨折发生的几率。全部6项研究表明本品能增加所有检测骨骼部位的骨密度。
本品的最常见不良反应为泌尿道感染，上呼吸道感染，坐骨神经痛，白内障，便秘，皮疹和肢体疼痛。

Prolia approved for postmenopausal osteoporosis
      
The FDA has approved Prolia (denosumab, from Amgen) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. This approval was based on data from a Phase 3 three-year study in 7,808 postmenopausal women with osteoporosis.
Treatment with Prolia demonstrated a 68% reduction in vertebral fractures, a 40% reduction in hip fractures, and a 20% reduction in non-vertebral fractures. Additionally, significant bone density increases were observed: 8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck.