Postmenopausal women with osteoporosis who took romosozumab for a year experienced “rapid and large reductions” in risk of fracturing vertebrae compared to placebo, notes research presented in Madrid at the 2017 Annual European Congress of Rheumatology.
The 3,591 postmenopausal women in the study who were given placebo treatment were five times likelier to experience fractures than the 3,589 administered romosozumab, an antibody given as an injection which inhibits a protein called sclerostin and increases bone density and formation. In the romosozumab group, fractures occurred in just the first two months of treatment, per a release.
“Clinical vertebral fracture risk was 83 percent lower in the romosozumab group versus placebo at 12 months,” the release stated. “Postmenopausal osteoporosis is considered a serious public health concern due to its high prevalence worldwide,” it added. “Approximately 30 percent of all postmenopausal women have osteoporosis in Europe and the U.S.; at least 40 percent of these women will go on to sustain one or more fragility fractures in their lifetime.”
Late last month, Reuters reported that romosozumab — which Amgen and UCB are calling evenity — isn’t expected to win U.S. Food and Drug Administration approval in 2017 “after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial.”
The increased heart attack risk could be 30 percent, per a Forbes article. “This is the absolute worst way for a drug to run into trouble: after two expensive, large studies are finished, as its makers prepare for a commercial launch,” the article stated. “It’s far better to figure out that a medicine won’t make it early, before all that money is spent.”
The FDA had been considering the drug, but following the new safety data, the decision is likely to be delayed “leaving the product’s future uncertain,” Reuters added.
In the study presented at the EULAR conference in Spain, however, Piet Geusens, of the Netherlands’ Maastricht University and lead author, praised the new drug class’ “highly effective treatment for postmenopausal women with osteoporosis with established bone mineral density (BMD) deficit who are at increased risk of fracture.”
“The rapid and large reduction in clinical vertebral fracture risk is an important and highly relevant clinical outcome,” he said in the release.
Prior studies also showed that injecting romosozumab on a monthly basis over a year increased both the trabecular and cortical compartments of the spine and hips. The release defined those as the “honeycombed matrix of bone lying under cortical bone” and the “hard, outer layer of bone” respectively.