Eldecalcitol Soft Capsules Approved in China for Osteoporosis Treatment

On December 16, the National Medical Products Administration of China announced that eldecalcitol soft capsules (eldecalcitol, development code ED-71), a new drug from Chugai Pharmaceutical Co., Ltd., a subsidiary of Roche, has been officially approved for marketing in China. Public information indicates that this is an active vitamin D3 derivative used for the treatment of osteoporosis, which was first launched in Japan in 2011.

Screenshot source: NMPA official website

Osteoporosis is a systemic skeletal disease characterized by decreased bone mineral density and bone quality, as well as deterioration of bone microarchitecture, leading to increased bone fragility and a heightened susceptibility to fractures. Statistics indicate that globally, one in three women and one in five men are at risk of osteoporotic fractures. Currently, the administration of active vitamin D, such as calcitriol and alfacalcidol, is a common pharmacological intervention for improving outcomes in patients with osteoporosis. These agents are particularly suitable for elderly individuals, patients with renal insufficiency, and those with 1α-hydroxylase deficiency.

Edicalcidol Soft Capsules are an active vitamin D3 derivative. In vitro studies have demonstrated that this product acts on human osteoclast precursors to inhibit osteoclast formation. Additionally, animal studies have shown that edicalcidol promotes calcium absorption in the small intestine and increases serum calcium levels. Edicalcidol simultaneously improves bone metabolism and enhances calcium absorption, thereby improving bone mineral density and bone strength, which ultimately reduces the incidence of osteoporotic fractures.

In March 2018, the New Drug Application (NDA) for eldecalcitol soft capsules was accepted by the Center for Drug Evaluation (CDE) in China. According to a press release previously issued by Chugai Pharmaceutical Co., Ltd. of Japan, the application was primarily based on the positive results from a pivotal Phase 3 clinical trial conducted in China. This randomized, double-blind, parallel-controlled study evaluated the efficacy and safety of eldecalcitol versus alfacalcidol in patients with primary osteoporosis. The primary endpoints were the percentage change from baseline in lumbar spine bone mineral density (L1–4 BMD) at 12 months, and the time course of the percentage change from baseline in lumbar spine BMD.

The results showed that, compared with patients in the control group, those receiving edocalcidiol had a statistically significant increase in BMD. The safety profile was consistent with previous reports. This study indicates that edocalcidiol is more effective than alfacalcidol in the treatment of primary osteoporosis, significantly increasing bone mineral density in patients, with a safety profile similar to that of alfacalcidol.

In China, osteoporosis has become a significant health issue among individuals aged 50 and older. The condition is particularly severe in middle-aged and elderly women. The goal of osteoporosis treatment is to prevent fractures and disorders of the musculoskeletal system associated with fractures and organ dysfunction. In severe cases, preventing bedridden status is a key therapeutic focus for maintaining and improving patients’ quality of life. Therefore, there is an urgent need for medications that can increase bone mineral density and reduce the risk of fractures.

References

[1] Notice from the National Medical Products Administration (NMPA) of China. Retrieved Dec 16, 2020, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20201216155331163.html

[2]New Drug Application of Eldecalcitol, an Active Vitamin D3 Derivative, for the Treatment of Osteoporosis Accepted in China. Retrieved Mar 22, 2018, from https://www.chugai-pharm.co.jp/english/news/detail/20180322150000_29.html

[4]Eldecalcitol, an Active Vitamin D3 Derivative, Increases Bone Mineral Density of Osteoporosis Patients in Chinese Phase III Study. Retrieved Nov 6, 2017, from https://www.chugai-pharm.co.jp/english/news/detail/20171106150000_58.html

[5] Zeng Jingping, Yan Hui, Wang Chenggang, et al. Osteoporosis treatment drugs—Eldecalcitol [J]. Drug Evaluation Research, 2011.

Source: Medicine Overview

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