The US Food and Drug Administration (FDA) has approved Amgen‘s Prolia, an injectable treatment for menopausal women with osteoporosis.
Prolia decreases destruction of bone and increases bone mass and strength for osteoporosis patients who have a high risk of fracture.
FDA approval is based on the three-year, double-blind, placebo-controlled, randomised trial of 7,808 postmenopausal women aged between 60 and 91 years.
The trial showed Prolia reduced the incidence of hip, vertebral and non-vertebral fractures in the subjects.
Serious adverse reactions include hypocalcaemia, serious infections and dermatologic reactions.