High-risk osteoporosis should increase bone formation first

Amgen Korea releases target therapy Evenity with dual effect

Increase bone formation and reduce resorption by inhibiting the activity of sclerostin

KSBMR Chair Chung Ho-yeon

“For a high-risk patient, it would be better to use effective bone-forming agent from the beginning.” Amgen Korea held a press conference held on Dec.

 

4 for the launch of Evenity (romosozumab-aqqg), where Chair Chung Ho-yeon of Korean Society for Bone and Mineral Research (KSBMR) stressed on the importance of top-down style prescription with the new option of osteoporosis treatment.

 

He urged medical professions should choose prioritized option recommended as a medication strategy for patients at high risk and in need of urgent treatment effect.

 

Particularly, Chung highlighted 12-month Evenity treatment showed increased bone formation effect in vertebral and hip fracture, more than with teriparatide.

 

A number of clinical data confirmed Evenity, compared to single therapy with alendronate, notably reduces risk in new vertebral or non-vertebral fracture.

 

“The prevalence rate of osteoporosis in age group over 50 has been constantly rising after 2008.

 

More than anything, osteoporosis within a year results in hip fracture for one out of five patients, and in vertebral fracture for one out of ten patients, which can lead to possible deaths”, Chair Chung emphasized.

 

Korean Ministry of Food and Drug Safety (MFDS) granted approval on Evenity in May 31.

 

Now Evenity can be used on treating severe osteoporosis in postmenopausal women at a high risk of fracture, and to increase bone mineral density for men with osteoporosis at a high risk of fracture.

 

A target therapy Evenity is the first dual-acting osteoporosis drug that increases bone growth by inhibiting the activity of sclerostin, a protein that regulates bone formation, and also inhibits bone resorption.

 

The treatment is administered once-monthly in two separate subcutaneous injections (105 mg each, 210 mg in total) on different body parts.

 

After administering full 12 doses, maintenance therapy with bone resorption inhibitor is needed.

 

MFDS’ approval was based on Phase 3 FRAME and ARCH studies treating postmenopausal women with osteoporosis, and Phase 3 BRIDGE study treating men with osteoporosis.

 

First, the Phase 3 FRAME trial compared Evenity with placebo in menopausal women with a T-score of -2.5 to -3.5 at the total hip or femoral neck.

 

And the result showed that the treatment lowered risk of new vertebral fracture.

 

Treated with Evenity for 12 months, the risk of new vertebral fracture was reduced by 73 percent compared with placebo.

 

Patients who switched to Prolia for 12 months after 12-month Evenity treatment had a 75 percent lower risk of new vertebral fracture compared to patients who switched to Prolia from placebo.

 

In the Phase 3 ARCH trial, comparing Evenity and alendronate, romosozumab showed outstanding preventive effect on postmenopausal women with osteoporosis and high risk of fracture by lowering incidence of both vertebral fracture and clinical fracture.

 

A group of patients, who switched to alendronate after 12-month Evenity treatment, lowered risk of new vertebral fracture by 50 percent at 24-month compared to a group with alendronate treatment only.

 

Also in BRIDGE trial comparing Evenity with placebo treating men with osteoporosis, 12 months of the treatment increased patient’s bone mineral density by 12.1 percent more than placebo, demonstrating a meaningful improvement in bone mineral density.

 

“The U.S.

 

Endocrine Society’s (ENDO) guideline revised in 2019 recommends bone formation agent as a first-line treatment for osteoporosis patient with fracture.

 

With dual effect of increasing bone formation and reducing bone resorption, Evenity can be considered as a prioritized option recommended for treating osteoporosis at super high risk”.