Trial Profile
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 03 Feb 2020
Price :
$35
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At a glance
- Drugs Romosozumab (Primary)
- Indications Male osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms BRIDGE
- Sponsors Amgen
- 11 Dec 2019 According to an Amgen media release,the European Commission (EC) has granted marketing authorization for EVENITY(romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. EVENITY is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption (or bone loss). The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in October 2019.
- 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.