Once spurned, Amgen wins the FDA over with its bone-building osteoporosis drug Evenity
As expected, Amgen’s once-rejected osteoporosis drug has scored FDA approval, paving the way for a new bone-building option for the one in two postmenopausal women in the United States whose weakened bones make them highly susceptible to fracturing.
Romosozumab is to be sold under the brand name Evenity. It functions predominantly as a bone anabolic agent that stimulates bone growth by inhibiting a protein called sclerostin, which ceases the production of bone and enhances its breakdown. The current standard of care for the 10 million Americans with osteoporosis is a family of drugs called bisphosphonates — such as alendronate (originally sold under the brand name Fosamax by Merck) — that thwart cells called osteoclasts that break down bone tissue but do not rebuild it.
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