Heart Safety Clouds Hopes for Amgen, UCB Bone Drug Approval

The medicine met the primary and key secondary goals of a late-stage study. The imbalance in heart-related side effects had not been observed in an earlier Phase III study that had been the basis of the regulatory submission seeking approvals.

In the new trial, romosozumab significantly reduced the incidence of new vertebral fractures through 24 months as well as non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture compared with Merck & Co’s Fosomax.

Serious heart problems were reported, however, in 2.5% of patients who received the Amgen drug, versus 1.9% in the Fosomax group.

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…

An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.

Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…

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…

Romosozumab Promising for Osteoporosis Treatment; Setbacks for Fulranumab Clinical Trials

FDA Advisory Committee Votes in Favor of Romosozumab Approval

Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis

Novel Bone Drug Promising in Postmenopausal Osteoporosis

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