A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
Phase of Trial: Phase III
Latest Information Update: 18 Oct 2019
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At a glance
- Drugs Romosozumab (Primary)
- Indications Male osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms BRIDGE
- Sponsors Amgen
- 18 Oct 2019 According to an UCB, Amgen media release, the CHMP's recommendation will now be reviewed by the European Commission (EC) with decision expected by year-end 2019.
- 18 Oct 2019 According to an UCB, Amgen media release, following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization for EVENITY(romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
- 27 Jun 2019 According to an Amgen, UCB Media release, the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITY(romosozumab) for the treatment of severe osteoporosis based on the results of 3 pivotal Phase 3 studies FRAME, ARCH and BRIDGE. Also the companies intend to submit a written notice for a re-examination by the Committee for Medicinal Products for Human Use.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History