Officials with the FDA have approved romosozumab-aqqg (Evenity, Amgen) for the treatment of osteoporosis in postmenopausal women at high risk of fracture, according to a press release. Romosozumab-aqqg is indicated for patients with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.

By blocking the effects of the protein sclerostin, romosozumab-aqqg works to decrease the risk of fracture by increasing new bone formation. With this approval, romosozumab-aqqg is the first and only bone builder with the dual effect of increasing bone formation and to a lesser extent reducing bone resorption, according to Amgen.

“But Evenity may increase the risk of heart attack, stroke, and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who had a heart attack or stroke within the previous year,” Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic Products, said in a statement.

Romosozumab-aqqg comes with a Boxed Warning advising about this risk.

The FDA’s decision to approve romosozumab-aqqg is based on safety and efficacy data from 2 clinical trials, the placebo-controlled FRAME study and the active-controlled ARCH study,  involving more than 11,000 women with postmenopausal osteoporosis.

In the FRAME trial, treatment with romosozumab-aqqg (210 mg administered monthly) significantly reduced new vertebral fracture at 12 months compared with a placebo. This significant reduction in fracture risk persisted through the second year in women who received romosozumab-aqqg during the first year and transitioned to denosumab compared with those who transitioned from placebo to denosumab, according to the study. Additionally, romosozumab-aqqg significantly increased bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck compared with a placebo at 12 months. The study continued to show that BMD continued to increase through month 24 in patients who transitioned from romosozumab-aqqg to denosumab at month 12.

The ARCH study demonstrated that treatment with romosozumab-aqqg followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months. Romosozumab-aqqg followed by alendronate significantly reduced the risk of clinical fracture after a median follow-up of 33 months, according to the data. Romosozumab-aqqg also significantly increased BMD at the lumbar spine, total hip, and femoral neck at 12 months compared with alendronate. Patients treated with romosozumab-aqqg for 12 months followed by 12 months of treatment with alendronate experienced a significant increase in BMD compared with alendronate alone.

“After spending 30 years caring for women with osteoporosis and in clinical research, I know that women at high risk of fracture need another therapy that reduces fractures quickly,” FRAME trial principal investigator Felicia Cosman, MD, professor of medicine at Columbia University College of Physicians and Surgeons, said in a statement. “Evenity acts by a novel mechanism to reduce the risk of new vertebral fracture within 12 months, and it produces rapid and dramatic improvements in bone mass. These benefits are sustained upon transition to an anti-resorptive medication and address a critical need for patients at high risk of fracture.”

Two injections, 1 immediately following the other, make up 1 dose of romosozumab-aqqg and is to be delivered once a month by a health care professional. The anabolic effect of romosozumab-aqqg wanes after 12 monthly doses of therapy, therefore the duration of use should be limited to 12 monthly doses, according to Amgen.

References

FDA Approves Evenity (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture [news release]. Amgen. https://www.amgen.com/media/news-releases/2019/04/fda-approves-evenity-romosozumabaqqg-for-the-treatment-of-osteoporosis-in-postmenopausal-women-at-high-risk-for-fracture/. Accessed April 9, 2019.

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture [news release]. FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635653.htm?utm_campaign=040919_PR_FDA%20approves%20new%20treatment%20for%20osteoporosis%20in%20postmenopausal%20women&utm_medium=email&utm_source=Eloqua. Accessed April 9, 2019.