The Food and Drug Administration (FDA) has approved Evenity (romosozumab-aqqg; Amgen) injection 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 therapies.
Evenity is a bone-forming monoclonal antibody designed to inhibit the action of sclerostin, a regulatory factor in bone metabolism. This allows the drug to rapidly increase bone formation and, to a lesser extent, decrease bone resorption.
Evenity is administered by subcutaneous injection once a month. As the anabolic effect of Evenity wanes after 12 monthly doses of therapy, duration of therapy should be limited to 12 monthly doses; treatment with an antiresorptive drug should be considered if continued osteoporosis therapy is needed.
The approval was based on data from two phase 3 clinical trials involving over 11,000 postmenopausal women aged 55–90 years old. In Study 1 (N=7180), patients were randomized to receive Evenity or placebo for 12 months. Results showed that Evenity significantly reduced the incidence of new vertebral fractures compared with placebo (relative risk reduction: 73% [95% CI: 53, 84]; P<.001). In addition, the significant reduction in fracture risk persisted through the second year in patients who received Evenity during the first year and transitioned to denosumab compared with those who transitioned from placebo to denosumab.
In Study 2 (N=4093), patients were randomized to receive Evenity or alendronate for 12 months; after the treatment period, patients in both arms were transitioned to open-label alendronate while remaining blinded to their initial treatment. Results showed that treatment with Evenity followed by alendronate significantly reduced the incidence of new vertebral fractures at 24 months compared with alendronate treatment alone (relative risk reduction: 50% [95% CI: 34, 62]; P<.001); the risk of nonvertebral fractures was also significantly reduced in patients treated with Evenity followed by alendronate vs alendronate alone (hazard ratio 0.81 [95% CI: 0.66, 0.99]; P=.04).
The most common adverse reactions associated with Evenity reported in clinical trials were arthralgia and headache.
Evenity carries a Boxed Warning regarding the potential risk of myocardial infarction, stroke, and cardiovascular death. “It’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year,” said Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.
Evenity is supplied as 105mg/1.17mL solution in a single-use prefilled syringe. A full dose requires 2 single-use prefilled syringes. It is expected to be available in about 1 week.
For more information visit amgen.com.