EMA gives nod to romosozumab for severe postmenopausal osteoporosis
medwireNews: The sclerostin inhibitor romosozumab has been recommended for approval in Europe, for the treatment of severe osteoporosis in postmenopausal women at high risk for fractures.
The EMA initially adopted a negative opinion on romosozumab for osteoporosis in June 2019, but has now recommended approval for this more restricted indication following a re-examination procedure.
Romosozumab will be available as a solution for injection, and the EMA recommends that treatment with the agent should be initiated and supervised by specialists who are experienced in the treatment of osteoporosis.
The recommendation for approval is based on study results demonstrating that romosozumab decreases the risk for vertebral and nonvertebral osteoporotic fractures in postmenopausal women with severe osteoporosis and high fracture risk. The EMA notes that “serious cardiovascular events are an important identified risk” associated with romosozumab treatment.
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