Human medicines European public assessment report (EPAR): Evenity, romosozumab, Osteoporosis, Date of authorisation: 09/12/2019, Revision: 4, Status: Authorised
Evenity has been studied in two main studies in postmenopausal women with osteoporosis and shown to reduce the incidence of fractures. One study, involving 7,180 women, compared Evenity with a placebo (dummy treatment) while the other, involving 4,093 women with severe osteoporosis, compared the medicine with alendronate, a standard medicine for treating osteoporosis.
In the first study, treatment with Evenity for 12 months reduced the number of new fractures detected by X-ray in the spine compared with placebo (16 cases in 3,321 Evenity-treated women versus 59 among 3,322 women given placebo). Benefit continued to be seen at 24 months, during which the women were maintained with another osteoporosis treatment, denosumab.
In the second study, in which 12 months’ treatment with Evenity (followed by maintenance treatment with alendronate) were compared with continuous alendronate treatment, Evenity again reduced the number of new fractures detected by X-ray in the spine at 12 months and benefit continued over the 12 months of alendronate maintenance: there were 74 new fractures in the spine detected by X-ray among 1,825 Evenity-treated women over the whole 24 months, compared with 147 among 1,834 women just given alendronate. When all clinical fractures both in the spine and elsewhere were analysed over the course of the study, after about 33 months, the results were 198 fractures among 2,046 given Evenity and 266 among 2,047 in the alendronate group.
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