The clinical effectiveness agency for England and Wales said that it would recommend denosumab, a medicine granted marketing authorization in Europe less than a month ago, to prevent a first or second bone fracture in some women with osteoporosis.
Denosumab is a human monoclonal antibody that targets a regulator of osteoclasts, the cells that break down bone. On May 28, the European Commission granted marketing approval to denosumab for treating osteoporosis in postmenopausal women at increased risk of fractures, and for bone loss associated with hormone ablation in men with prostate cancer, who are also susceptible to fractures.
The National Institute for Health and Clinical Excellence said in draft guidance issued June 18 that postmenopausal women who are at increased risk of osteoporotic fractures should be treated with denosumab if treatment with currently available oral bisphosphonates, a class of oral medications that prevent bone loss, is unsuitable or contraindicated.
NICE said in a news release that some women, particularly the very old or infirm, may not be able to comply with the requirement that they stand or sit upright for half an hour after taking a bisphosphonate. Denosumab is administered by injection; a single dose of 60 mg costs £183 and is given every 6 months.
Current treatments approved by NICE for women with osteoporosis who have not broken a bone include the bisphosphonates alendronate, risedronate, and etidronate, along with strontium ranelate, an oral medication that increases deposition of new bone. To prevent secondary fractures in women who have already broken a bone, NICE’s formulary is more extensive, including all of those drugs plus raloxifene, a medicine with estrogenic action on bone, and teriparatide, a recombinant form of parathyroid hormone, according to an agency statement.
NICE began its assessment of denosumab long in advance of its regulatory approval and said it expects to issue final guidance on the medication later this year.
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英格兰和威尔士临床疗效评价机构称其会推荐狄诺塞麦(Denosumab)——在近一个月之前获准于欧洲上市的药物——用于预防某些骨质疏松症女患者首次或再发生骨折。
狄诺塞麦是一种以破骨细胞(分解骨组织的细胞)调节因子为靶点的人源性单克隆抗体。5月28日，欧洲委员会证实批准狄诺塞麦上市，用于骨折风险增加的绝经后女性以治疗骨质疏松症，以及用于前列腺癌患者以预防激素剥夺治疗导致骨丢失，这类男患者同样易于发生骨折。
英国国家健康与临床优化研究所(NICE)在6月18日出版的指南草案中称，对于骨质疏松性骨折风险增加的绝经后女性，若其不适于采用当前可用的二膦酸盐口服药(一类防止骨丢失的口服药物)治疗或属于禁忌人群，则应该接受狄诺塞麦治疗。
NICE在新闻发布会上表示，服用二膦酸盐后要求患者站立或正坐0.5 h，这对于某些女性，特别是较年老或体弱的女性，可能难以做到。狄诺塞麦经注射用药；单剂为60 mg，费用为183英镑，每6个月用药1次。
对于尚未发生骨折的骨质疏松症女患者，当前NICE批准的治疗药包括二膦酸盐类药物阿仑膦酸盐、利塞膦酸盐、依替膦酸盐和雷奈酸锶(一种增加新骨沉积的口服药)。据当局的一则声明，对于有既往骨折史的女性二次骨折的预防，NICE的处方集覆盖面较广，包括所有上述药物加雷洛昔芬(对骨有雌激素功能的药物)和特立帕肽(重组甲状旁腺激素)。
NICE在监管部门批准狄诺塞麦之前很早就开始对该药进行评估，并称当局预计于今年下半年发布最终的用药指南。
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