Prolia: 10 Years of Osteoporosis Treatment & Expanded Access in Korea

A treatment for osteoporosis, Prolia (denosumab), is being recognized for a decade of impact in the South Korean market. Amgen Korea, led by President Shin Soo-hee, held an internal event on February 6th to celebrate the 10-year anniversary of Prolia’s launch and reaffirm its commitment to improving osteoporosis care within the country.

Prolia’s Decade of Progress

Prolia, an original denosumab formulation, has received approval in over 80 countries and has been used by more than 30 million patients globally. This widespread adoption is based on its demonstrated ability to reduce fracture risk, as confirmed by 10 years of long-term clinical research, and its convenient, bi-annual dosing schedule.

Did You Know? Prolia has been used by over 30 million patients in more than 80 countries.

During the anniversary event, Amgen Korea employees highlighted the positive changes Prolia has brought to osteoporosis treatment in South Korea over the past decade. They expressed a dedication to being a “10-point partner” – a trusted resource – for both patients and healthcare professionals.

Clinical Evidence Supporting Prolia

The clinical successes of Prolia are rooted in the FREEDOM and FREEDOM Extension studies. The initial FREEDOM study demonstrated improvements in bone density in the spine and hip, alongside a reduction in fracture risk. The subsequent FREEDOM Extension study, which tracked patients for a total of 10 years, continued to show sustained fracture risk reduction and a consistent safety profile.

Further supporting Prolia’s effectiveness, a large-scale Real World Evidence (RWE) study involving approximately 500,000 patients, and a Post-Marketing Surveillance (PMS) study focused on Korean patients, confirmed its effects and safety in real-world clinical settings.

Expert Insight: The long-term data from the FREEDOM and FREEDOM Extension studies are particularly significant, as they demonstrate sustained benefits and a consistent safety profile over an extended period, which is crucial for a chronic condition like osteoporosis.

Access to Prolia has expanded in South Korea. Initially approved as a first-line treatment for osteoporosis in 2019, coverage was further broadened in 2024 to allow for continued treatment for up to two years for patients whose T-score improves to between -2.5 and -2.0 during Prolia therapy.

Hye-na Kwon, Executive Vice President of Amgen Korea’s Osteoporosis Business Unit, stated that Prolia has “led a paradigm shift in domestic osteoporosis treatment” through its proven fracture risk reduction and long-term safety. She affirmed Amgen Korea’s commitment to collaborating with healthcare professionals to support patients and advance osteoporosis care in the country.

Frequently Asked Questions

What is Prolia used for?

Prolia (denosumab) is used to treat osteoporosis, a condition that weakens bones and increases the risk of fractures.

How often is Prolia administered?

Prolia is administered as an injection once every six months.

What clinical studies support the use of Prolia?

The FREEDOM and FREEDOM Extension studies, along with large-scale RWE studies and a Korean PMS study, have demonstrated Prolia’s effectiveness and safety.

How might expanded coverage for Prolia impact osteoporosis treatment in South Korea?