Amgen's Prolia® Approved in China for Treatment of Osteoporosis in Men at High Risk of Fracture

ShanghaiFebruary 24, 2023PR Newswire -- Amgen China today announced that Prolia^®(English name: Prolia^®; Generic Name: Denosumab Injection, approved by the National Medical Products Administration (NMPA) for the treatment of male osteoporosis patients at high risk of fractures. It helps improve bone mass and reduce the risk of fractures. Prolia^®Is EyeThe first and only one in ChinaAnti-RANKL monoclonal antibody drugs for the treatment of male osteoporosis have been approved this time, offering a new, safe, and effective treatment option for more patients in China.

Osteoporosis is an important health issue for the middle-aged and elderly population in China. It is estimated that by 2050, the number of osteoporosis patients in China will reach 120 million, with a prevalence rate of 6.46% among men over 50 years old.^[1,2]The situation is far from optimistic. The consequences of osteoporosis in men are often more severe. One in five men over the age of 50 will experience an osteoporotic fracture, and nearly 30% of hip fractures occur in men. The disability and mortality rates are significantly higher in male patients than in female patients, resulting in a heavy burden on families in terms of care and economic costs.^[2]However, for a long time, the diagnosis and treatment of osteoporosis in Chinese men have been overlooked, and the level of standardized diagnosis and drug treatment needs to be improved.

"Osteoporosis is often considered by the public as a disease that occurs more frequently in women. This misconception has led to lower awareness, consultation, and treatment rates for osteoporosis in men. Expanding treatment options and improving patient compliance are key to reducing the risk of osteoporosis and fragility fractures in men," stated Professor Zhang Zhenlin, Director of the Osteoporosis and Bone Disease Department at the Sixth People's Hospital affiliated with Shanghai Jiao Tong University School of Medicine and Chairman of the Chinese Society of Osteoporosis and Bone Mineral Research of the Chinese Medical Association. "This time, Prolia..."^®The approval of the indication for male patients meets the clinical need for treating male osteoporosis with anti-RANKL monoclonal antibody drugs. This innovative treatment solution is of great significance for the long-term bone health management and quality of life improvement in male patients.

Results from the global Phase III efficacy and safety study conducted in men with osteoporosis showed that, compared to placebo, Prolia...^®After 12 months of treatment, bone mineral density significantly increased in key areas such as the lumbar spine, total hip, femoral neck, and femoral trochanter.^[3]; After 24 months of treatment, bone mineral density continued to increase, with the lumbar spine and total hip bone mineral density increasing by 8.0% and 3.4% respectively compared to baseline; safety was good.^[4]。

Ms. Ada Hsu, Vice President of Amgen and General Manager of China, said: "We are very pleased to see Prolia^®Approved for male indications. Thus, Prolia^®Will jointly provide high-quality solutions for male and female patients with osteoporosis who meet the treatment criteria, benefiting a wider patient population. This also means that Amgen China will unlock greater potential in the field of bone health. Amgen has always focused on the medical needs of China’s aging population and chronic disease areas, and is committed to bringing globally leading innovative drugs to China to accelerate access for more Chinese patients. We will continue to strengthen cooperation with all parties to advance the progress of healthy aging initiatives in China and make a positive contribution to the construction of "Healthy China."

Prolia^®Previously approved in China for female indications and officially launched, it is used for osteoporosis in postmenopausal women at high risk of fractures. In postmenopausal women, it significantly reduces the risk of vertebral, non-vertebral, and hip fractures. This indication was included in the National Reimbursement Drug List (NRDL) through negotiation in 2020, greatly enhancing the affordability and accessibility of the drug, benefiting more patients in China.

References

1.  Li Mei, Zhang Zhenlin, Xia Weibo. Attention should be paid to the diagnosis and treatment of male osteoporosis as a common disease. Chinese Journal of Osteoporosis and Bone Mineral Research, 2022, 15(5): 449-454. doi:10.3969/j.issn.1674-2591.2022.05.002

2. Osteoporosis Society of Chinese Medical Association. Guidelines for the Diagnosis and Treatment of Male Osteoporosis. Chinese Journal of Osteoporosis and Bone Mineral Research, 2020, 13(5): 381-395. doi:10.3969/j.issn.1674-2591.2020.05.001

3.  Orwoll, E., et al. (2012). A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. The Journal of clinical endocrinology and metabolism, 97(9), 3161–3169.

4.  Langdahl, B. L., et al. (2015). A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial. The Journal of clinical endocrinology and metabolism, 100(4), 1335–1342.

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