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…
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…
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…
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 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…
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…
Aetna recently notified practices about the launch of its Combined Benefit Management Drug List, which will result in romosozumab-aqqg (Evenity) and infliximab (Remicade) moving to pharmacy-only coverage on July 1. The ACR is working to oppose this change.