Insights into osteoporosis treatments as societies around the world age.
Challenging Cases in Osteoporosis: Tips from an Expert
Using three complicated patient cases, Kenneth G. Saag, MD, MSc, shared his expertise on osteoporosis and walked through his thought process and the literature, during a session of the 2022 ACR Education Exchange.
FDA Greenlights Osteoporosis Drug for Postmenopausal Women
(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Romosozumab-aqqg belongs to a new…
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
Romosozumab Improves Bone Mineral Density in Men with Osteoporosis
NEW YORK (Reuters Health)—Romosozumab improves bone mineral density (BMD) in men with osteoporosis, but safety concerns are holding up its approval in the U.S. Up to 2 million men in the U.S. have osteoporosis, and up to 13 million have osteopenia, researchers note in a report online June 20 in The Journal of Clinical Endocrinology…
Romosozumab Has Biggest BMD Benefit in First Year of Treatment
NEW YORK (Reuters Health)—Romosozumab shows smaller benefits for increasing bone mineral density (BMD) in the second year of treatment compared to the first, new research suggests. The extension of a phase 2 study in postmenopausal women with low bone mass also found BMD decreased sharply when patients on romosozumab were switched to placebo after two…
Novel Bone Drug Promising in Postmenopausal Osteoporosis
NEW YORK (Reuters Health)—The investigational drug romosozumab led to gains in hip bone mineral density (BMD) that were not seen with teriparatide in older women with osteoporosis transitioning from bisphosphonate therapy in the STRUCTURE study. Amgen’s romosozumab is a monoclonal antibody that inhibits sclerosin, a negative regulator of bone formation. In addition to stimulating bone…
Rheumatology Drug Updates: Uncertain Future for Romosozumab, Plus FDA Approves Tocilizumab for GCA
Romosozumab’s Future Is Uncertain Romosozumab, which has the possible U.S. brand name Evenity, is awaiting approval from the FDA.1 The treatment is an investigational, injectable biologic for treating osteoporosis. It increases bone formation and bone density, reducing a patient’s risk of fractures. The manufacturer no longer expects the FDA to approve the drug this year…
FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA
Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…
Heart Safety Clouds Hopes for Amgen, UCB Bone Drug Approval
(Reuters)—Amgen Inc. and UCB SA no longer expect their experimental osteoporosis drug to win U.S. approval this year after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial. The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the…