Amin and Uber co-developed By Romosozumab with strong FDA support

Osteoporosis is a disease caused by decreased bone density and qualityThe bones of the human body are constantly changing living tissueThe process, called bone reconstruction, is that bone-breaking cells dissolve the bone matrix, while bone cells can accumulate bone matrixFor osteoporosis patients, bone dissolution loss exceeds the rate at which new bones grow, causing the bones to become porous and fragile, and the risk of fractures is greatly increasedtoday, Amgen and UCB announced that the joint development of The even-city (romozumab) has received strong support from theAdvisory(http://committee (BAUDAC) for the http://of thehttp://
FDAbased on The safety and efficacy of The(http://in two critical Phase 3 clinicaltrials, 18 of the 19 committee members recommended approval of the drug for the treatment of postmenopausal osteoporosis patients with a high risk of fractureseven
Evenity is a monoantigen that inhibits the activity of oscistin, which simultaneously accelerates bone formation and reduces bone absorptionOsteosclerosis protein is a secretie glycoproteinin vivo studies have shown that osteocyte is specifically expressed in osteocyte and inhibits bone formation in bone cellsThe symptoms of osteoporosis can be alleviated by antagonistic osteosclerosis protein, which provides new ideas and methods for the clinical treatment of osteoporosis and other diseasesIt was approved for listing in Japan just a week agorelated studies
BAUDAC reviewed the results of two key clinical Phase 3 trialsf
rame is a multicenter, international, randomized, double-blind, placebo-controlled, parallel group study trial in 7,180 women with postmenopausal osteoporosisPatients were randomly assigned to receive Evenity (210 mg) or placebo treatment for 12 months, followed by 12 months of denosumab (tinocy) treatmentTinnosis is an osteoporosis drug that Amin has been on the market forThe-rame trial was designed to assess the effectiveness and safety of Evenity in reducing the risk of new vertebral fractures at 12 and 24 months, respectivelytest top line results showthat that after 12 months of treatment, Evenity was able to reduce the risk of new vertebral fractures by 73% (p0.001) compared to the control groupAfter 24 months of treatment, Evenity was able to reduce the risk of new vertebral fractures by 75% (p00) .001ARCH is a randomized, double-blind, alendronate controlled trial in 4,093 patients with a history of past fractures, high risk of fractures, postmenopausal osteoporosisAfter 12 months of Evenity treatment (210 mg), at least 12 months of sodium aruncin (70 mg) is treated The ARCH trial aims to assess the effectiveness of Evenity in reducing the incidence of clinical fractures (vertebral fractures and non-vertebral fractures) and new vertebral fractures compared to the single sodium arunnida treatment trial top line results show that the Evenity-based treatment was 48% less likely to reduce the risk of new vertebral fractures (p0.001) after 24 months of treatment than the one-drug therapy of sodium alenpyridine .