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Literature DB >> 30805895

Romosozumab: First Global Approval.

Abstract

Romosozumab (EVENITY™) is a humanised monoclonal antibody against sclerostin being developed by Amgen and UCB for the treatment of osteoporosis. On the basis of favourable results from several phase III trials in postmenopausal women with osteoporosis, and a single trial in men with osteoporosis, romosozumab is being considered for marketing approval in the US, EU and Canada, and was recently approved for marketing in Japan. This article summarizes the milestones in the development of romosozumab leading to this first approval for the treatment of osteoporosis in patients at high risk of fracture.

Entities: Chemical Disease Gene Species

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Year: 2019 PMID： 30805895 DOI： 10.1007/s40265-019-01072-6

Source DB: PubMed Journal: Drugs ISSN： 0012-6667 Impact factor: 9.546

11 in total

1. Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody.

Authors: Desmond Padhi; Graham Jang; Brian Stouch; Liang Fang; Edward Posvar
Journal: J Bone Miner Res Date: 2011-01 Impact factor: 6.741

2. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.

Authors: Bente L Langdahl; Cesar Libanati; Daria B Crittenden; Michael A Bolognese; Jacques P Brown; Nadia S Daizadeh; Eva Dokoupilova; Klaus Engelke; Joel S Finkelstein; Harry K Genant; Stefan Goemaere; Lars Hyldstrup; Esteban Jodar-Gimeno; Tony M Keaveny; David Kendler; Peter Lakatos; Judy Maddox; Jorge Malouf; Fabio E Massari; Jose Fernando Molina; Maria Rosa Ulla; Andreas Grauer
Journal: Lancet Date: 2017-07-26 Impact factor: 79.321

3. Romosozumab in postmenopausal women with low bone mineral density.

Authors: Michael R McClung; Andreas Grauer; Steven Boonen; Michael A Bolognese; Jacques P Brown; Adolfo Diez-Perez; Bente L Langdahl; Jean-Yves Reginster; Jose R Zanchetta; Scott M Wasserman; Leonid Katz; Judy Maddox; Yu-Ching Yang; Cesar Libanati; Henry G Bone
Journal: N Engl J Med Date: 2014-01-01 Impact factor: 91.245

4. Romosozumab Treatment in Postmenopausal Women with Osteoporosis.

Authors: Felicia Cosman; Daria B Crittenden; Jonathan D Adachi; Neil Binkley; Edward Czerwinski; Serge Ferrari; Lorenz C Hofbauer; Edith Lau; E Michael Lewiecki; Akimitsu Miyauchi; Cristiano A F Zerbini; Cassandra E Milmont; Li Chen; Judy Maddox; Paul D Meisner; Cesar Libanati; Andreas Grauer
Journal: N Engl J Med Date: 2016-09-18 Impact factor: 91.245

5. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study.

Authors: Hideaki Ishibashi; Daria B Crittenden; Akimitsu Miyauchi; Cesar Libanati; Judy Maddox; Michelle Fan; Li Chen; Andreas Grauer
Journal: Bone Date: 2017-07-05 Impact factor: 4.398

6. Romosozumab FRAME Study: A Post Hoc Analysis of the Role of Regional Background Fracture Risk on Nonvertebral Fracture Outcome.

Authors: Felicia Cosman; Daria B Crittenden; Serge Ferrari; E Michael Lewiecki; Juan Jaller-Raad; Cristiano Zerbini; Cassandra E Milmont; Paul D Meisner; Cesar Libanati; Andreas Grauer
Journal: J Bone Miner Res Date: 2018-05-11 Impact factor: 6.741

7. Sclerostin antibody treatment increases bone formation, bone mass, and bone strength in a rat model of postmenopausal osteoporosis.

Authors: Xiaodong Li; Michael S Ominsky; Kelly S Warmington; Sean Morony; Jianhua Gong; Jin Cao; Yongming Gao; Victoria Shalhoub; Barbara Tipton; Raj Haldankar; Qing Chen; Aaron Winters; Tom Boone; Zhaopo Geng; Qing-Tian Niu; Hua Zhu Ke; Paul J Kostenuik; W Scott Simonet; David L Lacey; Chris Paszty
Journal: J Bone Miner Res Date: 2009-04 Impact factor: 6.741

8. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.

Authors: Kenneth G Saag; Jeffrey Petersen; Maria Luisa Brandi; Andrew C Karaplis; Mattias Lorentzon; Thierry Thomas; Judy Maddox; Michelle Fan; Paul D Meisner; Andreas Grauer
Journal: N Engl J Med Date: 2017-09-11 Impact factor: 91.245

9. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis.

Authors: E Michael Lewiecki; Tomasz Blicharski; Stefan Goemaere; Kurt Lippuner; Paul D Meisner; Paul D Miller; Akimitsu Miyauchi; Judy Maddox; Li Chen; Stephane Horlait
Journal: J Clin Endocrinol Metab Date: 2018-09-01 Impact factor: 5.958

Review 10. Romosozumab for the treatment of osteoporosis.

Authors: Michael R McClung
Journal: Osteoporos Sarcopenia Date: 2018-03-27

11 in total

1. Osteoporosis drugs for prevention of clinical fracture in white postmenopausal women: a network meta-analysis of survival data.

Authors: L-L Ding; F Wen; H Wang; D-H Wang; Q Liu; Y-X Mo; X Tan; M Qiu; J-X Hu
Journal: Osteoporos Int Date: 2020-01-30 Impact factor: 4.507

Review 2. The Contribution of Wnt Signaling to Vascular Complications in Type 2 Diabetes Mellitus.

Authors: Raquel Sanabria-de la Torre; Cristina García-Fontana; Sheila González-Salvatierra; Francisco Andújar-Vera; Luis Martínez-Heredia; Beatriz García-Fontana; Manuel Muñoz-Torres
Journal: Int J Mol Sci Date: 2022-06-23 Impact factor: 6.208

3. Increase in bone turnover markers in HIV patients treated with tenofovir disoproxil fumarate combined with raltegravir or efavirenz.

Authors: Yonatan Oster; Matan J Cohen; Rivka Dresner-Pollak; Auryan Szalat; Hila Elinav
Journal: Bone Rep Date: 2020-10-16

4. Single-Cell RNA Sequencing of Calvarial and Long-Bone Endocortical Cells.

Authors: Ugur M Ayturk; Joseph P Scollan; Didem Goz Ayturk; Eun Sung Suh; Alexander Vesprey; Christina M Jacobsen; Paola Divieti Pajevic; Matthew L Warman
Journal: J Bone Miner Res Date: 2020-07-20 Impact factor: 6.741

5. Clinical efficacy and safety of drug interventions for primary and secondary prevention of osteoporotic fractures in postmenopausal women: Network meta-analysis followed by factor and cluster analysis.

Authors: Fei Wen; Hongheng Du; Liangliang Ding; Jinxi Hu; Zifeng Huang; Hua Huang; Kaikai Li; Yuxia Mo; Anyin Kuang
Journal: PLoS One Date: 2020-06-03 Impact factor: 3.240