Advances in new drugs for osteoporosis! FDA accepts Amgen monoclonal antibody romosozumab listing application
September 29, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Amgen, a US biotech giant, and its partner UBC recently announced that the US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for the review of osteoporosis new drug romosozumab, and also specified prescription drug user fees. (PDUFA) The target date is July 17, 2017. Romosozumab is a monoclonal antibody drug, and this BLA seeks to approve the treatment of postmenopausal women with osteoporosis for increased fracture risk.
The submission of romosozumab BLA is based on positive data from the critical phase III clinical study FRAME. FRAME is a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group phase III study conducted in women with postmenopausal osteoporosis who evaluated the efficacy of romosozumab (subcutaneous injection, once a month) And security. In the study, patients were randomized to romosozumab or placebo for 12 months, followed by a 12-month open-label treatment of Prolia (denosumab, denosumab). Among them, Prolia is an osteoporosis drug that Amgen has listed. The aim of the study was to determine whether romosozumab was effective in reducing the risk of fracture in women with postmenopausal osteoporosis at 12 and 24 months.
The data showed that the risk of new vertebral fractures at the 12 and 24 months of treatment was significantly lower in the romosozumab-treated group than in the placebo group, reaching the common primary end point of the study. In addition, the risk of clinical fractures (vertebral fractures + non-vertebral fractures) was significantly reduced in the romosozumab-treated group at 12 months of treatment compared with the placebo group, reaching one of the secondary endpoints of the study. However, compared with the placebo group, the risk of non-vertebral fractures at 12 months and 24 months of the study in the romosozumab group did not decrease, failing to reach another secondary endpoint of the study.
Specific data: At 12 months of treatment, the risk of vertebral (spinal) fractures was reduced by 73% in the romosozumab-treated group compared with the placebo group, with statistically significant differences. This effect was maintained in the second year when it was switched to denosumab treatment. Specifically, the treatment group from romosozumab to denosumab was more likely to develop new vertebral fractures at 24 months compared with the placebo-treated denosumab treatment group. The reduction was 75% and the data was statistically significant. In addition, the relative risk of clinical fractures in the romosozumab-treated group was significantly reduced by 36% in the first 12 months of treatment compared with the placebo group, and the data were also statistically significant.
About romosozumab:
Romosozumab is a fully humanized monoclonal antibody that promotes bone formation and reduces bone resorption by inhibiting the activity of sclerostin. This drug is an experimental drug developed jointly by Amgen and UCB. Any regulatory approval.
Currently, romosozumab is in the midst of a large global phase III clinical trial to investigate the potential to reduce fracture risk. The project included two large fracture clinical studies conducted in more than 10,000 postmenopausal osteoporosis patients to investigate the efficacy, safety, and tolerability of romosozumab relative to placebo or active control drugs. A previously published phase III STRUCTURE study showed that rososozumab (subcutaneous injection, 210 mg once a month) for women with postmenopausal osteoporosis is significantly better than Lilly's once-a-day osteoporosis drug. Peptide (teriparatid, subcutaneous injection, 20 micrograms, once daily).
Another key placebo-controlled phase III BRIDGE study published in March this year showed that romosozumab has a significant effect in the male patient population of osteoporosis.
Sclerostin, also known as sclerostin, is encoded by the osteosclerosis gene (SOST) and is a secreted glycoprotein. In vivo studies have demonstrated that osteosclerin is specifically expressed in osteocytes and plays an important role in bone metabolism by acting on osteoblasts. The expression of SOST gene is affected by stress, hormone, oxygen concentration and other factors. Antagonizing osteosclerosis can alleviate the symptoms of osteoporosis, which provides new ideas and new methods for clinical treatment of osteoporosis and other diseases.
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