Romosozumab joins the growing list of monoclonal antibody drugs that treat osteoporosis in postmenopausal women.
After positive results from 3 clinical trials, romosozumab (EVENITY) could be the next popular drug to treat severe osteoporosis in postmenopausal women at a high risk of fracture with no history of myocardial infarction or stroke.
Romosozumab is a bone-forming monoclonal antibody that works by inhibiting the activity of sclerostin, resulting in increased bone formation and to a lesser extent decreased bone resorption.
To test the effectiveness of the treatment, investigators recently conducted a randomized, double-blind, placebo-controlled study dubbed FRAME (Fracture study in postmenopausal women with osteoporosis).
The study included 7180 postmenopausal women with osteoporosis at risk for fracture who were given either 210 mg of romosozumab monthly for 12-months or a placebo.
The investigators also evaluated the effectiveness of treating with romosozumab for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months.
In another randomized, double-blind, alendronate-controlled study—ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture)—tested the medication in 4093 postmenopausal women with osteoporosis and previous fracture history.
The event-driven study evaluated 12 months of 210 mg of treatment administered monthly, followed by at least 12 months of 70 mg of alendronate treatment.
They compared the results with patients who received alendronate treatment alone, to assess its efficacy in reducing the risk of clinical fracture through the primary analysis period and the incidence of new vertebral fracture at 24 months.
A third trial—BRIDGE (Placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis)—assessed 245 men aged 55-90 with osteoporosis and a history of fragility fracture (excluding hip fracture) or vertebral fracture.
The study evaluated the effectiveness of 210 mg of monthly treatment for 12 months, compared with placebo, in increasing bone mineral density (BMD) at the lumbar spine and the effect on BMD at the femoral neck and total hip.
Argen, and UCB, which produces EVENITY, recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending Marketing Authorization following a re-examination procedure.
"After a fracture, postmenopausal women with osteoporosis are 5 times more likely to fracture in the subsequent year, and these fractures can be life-changing," David M. Reese, MD, executive vice president of Research and Development at Amgen, said in a statement. "We are pleased by the Committee's opinion because we believe EVENITY is an important therapeutic development for osteoporosis, and we look forward to the European Commission's decision later this year."
Post-menopausal osteoporosis and fragility fractures are undiagnosed and untreated in an estimated 77 percent of women at least 67 years old in the first 6 months following a fracture, according to Pascale Richetta, executive vice president of UCB.
Monoclonal antibody drugs like romosozumab and denosumab are commonly prescribed to treat patients suffering from osteoporosis.
In an interview with MD Magazine®, Beatrice Edwards, MD, deputy associate chief of staff of geriatrics and extended care for the Central Texas Veterans Health Care System, explained the risk and the reward behind this new class of drugs.
Edwards explained that romosozumab can be used for patients who have likely failed first-line treatment.
She also said the drugs are only effective for 12 months because after that they generate neutralizing antibodies.
EVENITY is approved in U.S. for the treatment of osteoporosis in postmenopausal women at high risk for fracture, as well as in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture.
The medication is also approved in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture, and in Australia for the treatment of osteoporosis in postmenopausal women at high risk of fracture and as a treatment to increase bone mass in men with osteoporosis at high risk of fracture.