Amgen has secured approval from the US Food and Drug Administration (FDA) for its Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk for fracture.
Evenity is a bone-building humanized monoclonal antibody developed to inhibit the activity of sclerostin. It is claimed to be the only bone builder that simultaneously increases bone formation and decreases bone resorption.
As per the World Health Organization (WHO), osteoporosis is a major public health crisis that is affecting millions of people across the world.
The approval of Evenity was based on data from the two phase 3 studies, including FRAME study and ARCH study.
FRAME (fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study, which assessed 7,180 postmenopausal women with osteoporosis.
ARCH (active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) is a randomized, double-blind, alendronate-controlled study, which evaluated 4,093 postmenopausal women with osteoporosis and previous fracture history.
In the placebo-controlled FRAME study, the patients treated with Evenity experienced a significant reduction in new vertebral (spine) fracture at 12 months compared against placebo.
The trial also showed that Evenity considerably increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared against placebo at 12 months.
In the active-controlled ARCH study, the patients treated with Evenity for 12 months followed by 12 months of alendronate experienced a significant reduction in the incidence of new vertebral fracture at 24 months.
The study also demonstrated that Evenity significantly increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared against alendronate.
Amgen research and development executive vice president Dr David Reese said: “One in two women will experience a fracture due to osteoporosis in her lifetime. These fractures can be devastating, with many leading to hospital stays and life-altering consequences.
“The FDA approval of Evenity represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months.”