Evenity (romosozumab-aqqg)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2019

Specific Treatments:

osteoporosis in postmenopausal women at high risk for fracture

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General Information

Evenity (romosozumab-aqqg) is a humanized monoclonal antibody (IgG2) and inhibits sclerostin, a glycoprotein secreted by osteocytes that has anti-anabolic effects on bone.

Evenity is specifically indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Evenity is supplied as an injection for subcutaneous administration. 

The anabolic effect of Evenity wanes after 12 monthly doses of therapy. Therefore, the duration of Evenity use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. 

Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of Evenity. Inject two 105 mg/1.17 mL prefilled syringes, one after the other.  Evenity should be administered by a healthcare provider.

The recommended dose of Evenity is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer once every month. The treatment duration for Evenity is 12 monthly doses. Patients should be adequately supplemented with calcium and vitamin D during treatment with Evenity. If a dose is missed, administer as soon as it can be rescheduled. Thereafter, Evenity can be scheduled every month from the date of the last dose. 

Clinical Results

FDA Approval

The FDA approval of Evenity was based on two phase III trial, FRAME and ARCH.

FRAME (Fracture study in postmenopausal women with osteoporosis) was a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the efficacy of Evenity treatment (210 mg administered monthly), compared with placebo, in reducing the incidence of new vertebral fractures through 12 months. The study also evaluated the efficacy of treating with Evenity for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the incidence of new vertebral fractures through 24 months. Treatment with Evenity resulted in a significant reduction of new vertebral (spine) fracture at 12 months compared to placebo. This significant reduction in fracture risk persisted through the second year in women who received Evenity during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab. In addition, Evenity significantly increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from Evenity to denosumab at month 12, BMD continued to increase through month 24.

ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) was a randomized, double-blind, alendronate-controlled study of Evenity in 4,093 postmenopausal women with osteoporosis and previous fracture history. This event-driven study evaluated 12 months of Evenity treatment (210 mg administered monthly) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to assess its efficacy in reducing the risk of clinical fracture (non-vertebral fracture and symptomatic vertebral fracture) through the primary analysis period and the incidence of new vertebral fracture at 24 months. Treatment with Evenity for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months. Evenity followed by alendronate significantly reduced the risk of clinical fracture (defined as a composite of symptomatic vertebral fracture and nonvertebral fracture) after a median follow-up of 33 months. Evenity significantly increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate. Twelve months of treatment with Evenity followed by 12 months of treatment with alendronate significantly increased BMD compared with alendronate alone.

Side Effects

Adverse effects associated with the use of Evenity may include, but are not limited to, the following:

arthralgia

headache

The Evenity drug label comes with the following Black Box Warning: Evenity may increase the risk of myocardial infarction, stroke and cardiovascular death. Evenity should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, Evenity should be discontinued.

Mechanism of Action

Evenity (romosozumab-aqqg) is a humanized monoclonal antibody (IgG2) and inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength. 

Additional Information

For additional information regarding Evenity or osteoporosis in postmenopausal women at high risk for fracture, please visit https://www.evenity.com/