An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.... [Read More]
FDA Advisory Committee Votes in Favor of Romosozumab Approval
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… [Read More]
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… [Read More]
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… [Read More]
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…... [Read More]
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…... [Read More]
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…... [Read More]
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…... [Read More]
The 2020 ACR Review Course: Key Issues Rheumatologists Face
The ACR Review Course featured eight talks providing a practical review of issues encountered by rheumatologists.... [Read More]
Osteoporosis Drugs Don’t Reduce Overall Mortality
NEW YORK (Reuters Health)—Anti-fracture medications do not reduce overall mortality in older patients with osteoporosis, according to an updated systematic review and meta-analysis. “This meta-analysis suggests drug treatments, including treatment with bisphosphonates, for osteoporosis should be recommended only for the prevention of fracture and not for any additional reduction in mortality,” researchers write in JAMA… [Read More]