Evenity can be prescribed at general hospitals

Evenity passed DC of Big 5, and can be prescribed at 30 hospitals

From December, reimbursed for secondary therapy

According to related industries, Amgen's bone formation promotion and bone resorption inhibitor Evenity (Romosozumab) has so far been prescribed in Big 5 general hospitals such as SMC, SNUH, Seoul St.

 

hospital, AMC, and Shinchon Severance Hospital, and has passed the drug commitee (DC) of about 30 medical institutions such as Gangnam Severance Hospital, Pusan National University Hospital, Bundang Seoul National University Hospital, and Hanyang University Hospital.

 

Amgen submitted an application for registration about one year after Evenity's domestic approval in May 2019, and was recognized for the adequacy of benefits from the HIRA's Pharmaceutical Benefit Advisory Committee in September.

 

The approved indications are ▲treatment of postmenopausal female osteoporosis patients at high risk of fracture, and ▲higher bone density of male osteoporosis patients at high fracture risk.

 

However, the benefit was limited to patients who were unable to use or were unable to use one or more of the bisphophonate drugs (although new fractures occurred despite sufficient administration for more than 1 year).

 

The duration of administration is limited to a total of 12 times at intervals of one month from a lifetime, and when the bone density test is performed after the administration of the drug and the same or improvement compared to the baseline value is confirmed, the administration to a bone resorption inhibitor is permitted.

 

However, as the registration process for new osteoporosis drugs in Korea was not easy, the registration of Evenity is encouraging.

 

In the case of Forsteo (Teriparatide)', it took 10 years to register after approval.

 

Professor Deok-yoon Kim of the Department of Endocrinology at Kyung Hee University Hospital said, "It is important to lower the risk of fracture with powerful drugs such as Evenity from the beginning of treatment for the ultra-high risk group for osteoporosis fracture.

 

The application of Evenity is expected to enable customized treatment for the ultra-high risk group." The effectiveness of Evenity was confirmed through a phase 3 study FRAME and ARCH study, and a phase 3 clinical BRIDGE study in men with osteoporosis.

 

Through FRAME, a placebo-controlled phase 3 clinical trial, Evenity showed the effect of lowering the risk of vertebral fracture in postmenopausal female patients with a high risk of fracture from -2.5 to -3.5 in anterior hip or femoral neck bone density T-score.

 

In ARCH, an Alendronate-controlled phase 3 clinical trial, Evenity demonstrated superior preventive effects in both vertebral and clinical fractures compared to Alendronate in postmenopausal female patients with osteoporosis and fragile fractures.

 

In the group that switched to Alendronate after 1 year of Evenity treatment, the risk of new vertebral fractures was reduced by 50% at 24 months compared to the continuous Alendronate group.