Amgen has received the US Food and Drug Administration (FDA) approval for Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk for fracture.
Evenity is a humanised monoclonal antibody designed to inhibit sclerostin in order to improve bone formation and to some extent decrease bone loss.
One dose of the drug comprises two injections and a full course consists of 12 monthly doses.
Following these 12 doses, the bone forming effect of the drug diminishes and further therapy with an anti-resorptive agent is recommended to address the chronic condition.
Osteoporosis, which lacks cure, affects nearly ten million people in the US. Bone breaks are a common occurrence in these patients and the condition is known to cause around two million fractures per year.
Postmenopausal women are at a high risk of loss of mobility due to osteoporosis-related fractures.
Amgen Research and Development executive vice-president 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.”
The FDA approval comes after review of findings from Phase III FRAME and ARCH clinical trials.
In FRAME, Evenity led to a significant decrease in new vertebral fracture at 12 months, compared to placebo. The decrease was retained through the second year in patients who received the drug during the first year and transitioned to denosumab.
Furthermore, patients treated with Amgen’s drug experienced increase in bone mineral density (BMD) at the lumbar spine, total hip and femoral neck at 12 months, which continued through month 24.
The ARCH study involved treatment with Evenity and alendronate for 12 months each. This minimised the incidence of new vertebral fracture at 24 months and the risk of clinical fracture after a median 33-month follow-up.
In addition, 12 months of treatment with Evenity followed by 12 months alendronate therapy significantly improved BMD, compared to alendronate alone.
Evenity comes with a boxed warning of potential increase in the risk of heart attack, stroke and cardiovascular death. The drug will be commercially launched in the US next week.