Amgen Korea said Monday an extended clinical trial for its osteoporosis treatment, Prolia, proved the drug’s “superior fracture prevention and a consistent safety profile” for long-term treatment.
Osteoporosis is a condition that weakens bones over time to make them thinner, more brittle, and more likely to break.
Prolia (ingredient: denosumab) is a monoclonal antibody injection that targets Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL) proteins in osteoporosis patients. These proteins are essential in forming, activating, and prolonging osteoclasts, a type of bone cell that breaks down bone tissue.
As the “first and only” biologic treatment for osteoporosis, Prolia is a hypodermic injection administered once every six months to postmenopausal women with the chronic illness, the company said.
The treatment gained approval in Nov. 2016 as the first RANKL-targeted osteoporosis treatment in Korea.
According to the FREEDOM Extension study, lumbar and hip bone mineral density of those who took Prolia long-term increased significantly compared to those who took the placebo (21.7 percent vs. 9.2 percent). A total of 2,626 women completed the trial.
The Prolia group also consistently showed a low rate of new fracture occurrences at 0.90-1.86 percent for the spine and 0.84-2.55 percent for non-spinal areas.
Serious adverse effects also remained consistently low, proving the drug’s safety profile, the company said.
“If osteoporosis patients do not get treatment, it increases the risk of fracture and possibly lowers their quality of life. It is therefore essential that patients select an optimum treatment clinically proven for long-term safety,” a company official said. “In this regard, we expect that Prolia – with a consistent safety profile and superior fracture prevention – will play an increasing role in helping domestic osteoporosis patients.”
The results from the FREEDOM Extension trial was published in the recent issue of the international medical journal Lancet Diabetes Endocrinology, the company said.
Amgen암젠코리아 (CEO: Noh Sang-kyung노상경) is waiting for final drug listing in Korea, having passed the Health Insurance Review & Assessment Service’s (HIRA) evaluations in June with the new data that proved the drug’s long-term effectiveness and safety, according to the company.