Amgen's Prolia® Gains New NMPA Approval for Glucocorticoid-Induced Osteoporosis in High Fracture Risk Patients
Amgen
Developer of Treatment Drugs for Serious Diseases
Amgen China announced, Prolia®(English name: Prolia®Generic Name: Denosumab Injection, has been approved by the National Medical Products Administration for the treatment of glucocorticoid-induced osteoporosis in patients at high risk of fractures. It can increase bone density and reduce the risk of fractures. This approval provides a new treatment option for patients with glucocorticoid-induced osteoporosis, who have long suffered from a lack of effective therapeutic drugs, and also adds an effective protective barrier to reduce the risk of fracture-related disabilities and alleviate the economic burden on society and families.
Glucocorticoid-induced osteoporosis (GIOP) is a skeletal disease characterized by reduced bone strength and increased fracture risk associated with long-term use of glucocorticoids, and it is the most common form of secondary osteoporosis.
GIOP patients face the risk of acute bone loss in the early stage of using glucocorticoids, losing 12%~20% of bone mass within the first year, and an additional approximately 3% each year thereafter.[1]; Long-term use of glucocorticoids increases the risk of vertebral fractures by 5.9 times and the risk of hip fractures by 5 times.[2], seriously endangering patients' health.
The incidence of GIOP in China is high, with up to 90% of rheumatism patients undergoing hormone therapy experiencing bone loss and osteoporosis, and over 40% being diagnosed with osteoporosis.[3]. However, for a long time, the clinical diagnosis and treatment of GIOP have faced many difficulties, with low public awareness and insufficient clinical attention. About one-third of patients have never received any standardized treatment.[1]; and there are fewer choices for anti-osteoporosis drugs approved for GIOP indications, making it difficult to meet the clinical needs of GIOP patients.
This approval is based on the results of a Phase III efficacy and safety study conducted in global GIOP patients. The study results showed that, whether in patients who have been taking glucocorticoids long-term (treated for 3 months or longer before the trial) or in newly treated patients (treated for less than 3 months before the trial), Prolia®At 12 months of treatment, it showed a higher increase in lumbar spine bone mineral density (BMD) compared to the control group (risedronate sodium). The therapeutic effect was not influenced by gender, age, race, or menopausal status, and it demonstrated good safety.[4]。
So far, Prolia®In China, three indications have been approved: In 2020, it was approved for the treatment of osteoporosis in postmenopausal women at high risk of fractures. In 2023, it was approved for the treatment of osteoporosis in men at high risk of fractures. Both indications are eligible for medical insurance reimbursement. This newly approved GIOP indication will also be directly eligible for medical insurance reimbursement.
References:
[1] Chinese Rheumatology Association of the Chinese Medical Doctor Association, Rheumatology Society of the Chinese Medical Association, Osteoporosis and Bone Mineral Research Society of the Chinese Medical Association, et al. 2020 Chinese Expert Consensus on Prevention and Treatment of Glucocorticoid-Induced Osteoporosis [J]. Chinese Journal of Internal Medicine, 2021, 60(1): 13-21. DOI: 10.3760/cma.j.cn112138-20201102-00914
[2] Steinbuch M, Youket T, Cohen S. Oral glucocorticoid use is associated with an increased risk of fracture. Osteoporosis Int. 2004; 15: 323-8.
[3] Zhang Xuewu, Yao Haihong, Mei Yifang, et al. Osteoporosis Survey of Rheumatism Patients Using Glucocorticoids in a National Multicenter Study in China [J]. Chinese Journal of Clinical Immunology and Allergy, 2017;11(3):277-84.
[4] Saag KG, Wagman RB, Geusens P, et al. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454.
About Prolia®(Denosumab)
Prolia®(English name: Prolia®; Generic Name: Denosumab Injection, is the world's first approved specific targeted anti-RANKL therapy. Currently, Prolia®Has been approved for marketing in more than 80 countries and regions worldwide.
Editor: Muyan
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