An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
Search results for: romosozumab
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…
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…
Romosozumab Promising for Osteoporosis Treatment; Setbacks for Fulranumab Clinical Trials
Two studies have shown that romosozumab is effective for increasing bone mineral density in both men and women with osteoporosis. And due to safety concerns, Janssen has dropped out of clinical trials for fulranumab, which is being studied to treat OA pain…
The ACR Addresses the FDA about the Safe Adoption of Biosimilars in the U.S.; Plus Tofacitinib Approved for RA & Romosozumab May Reduce Fracture Risk
The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising
The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…
ACR Releases Update to Glucocorticoid-Induced Osteoporosis Guideline
The ACR recently released an update on the prevention and treatment of glucocorticoid-induced osteoporosis.1 The guideline, which includes information on the new therapies abaloparatide and romosozumab, emphasizes the importance of shared decision making by patients and clinicians, and also gives information on the importance of sequential therapy after stopping certain osteoporotic prevention therapies. Fracture Prevention…
Updated Guideline Introduces Recommendations for Prevention & Treatment of Glucocorticoid-Induced Osteoporosis
ATLANTA—The ACR released a summary of its updated guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis in September. Many patients take glucocorticoids for a variety of inflammatory conditions, and anyone who is taking glucocorticoid medications and has other risk factors for osteoporosis increases their risk of developing glucocorticoid-induced osteoporosis. New osteoporosis medications and new…