(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture.
Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals.
Romosozumab-aqqg belongs to a new class of drugs known as sclerostin inhibitors.
One dose of romosozumab-aqqg consists of two injections, one immediately following the other, given once a month by a healthcare professional. The bone forming effect wanes after 12 doses, so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown.
Romosozumab-aqqg comes with a boxed warning, the FDA’s strictest warning, flagging increased risk of heart attack, stroke and cardiovascular-related death.
The approval is expected to augment sales at Amgen, which faces competition from cheaper rivals for two of its biggest selling products—the white blood cell booster pegfilgrastim (Neulasta) and rheumatoid arthritis drug etanercept (Enbrel).
However, William Blair Analyst Matt Phipps expects the initial demand to be slow due to the cardiovascular risks, and expects peak sales of $500 million.
“It’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year,” Hylton Joffe, director at FDA’s Center for Drug Evaluation and Research, says.
Amgen says the drug would be launched in April and it will unveil the price of the drug as well.
The decision comes months after an FDA panel overwhelmingly voted for the drug’s approval.
The market for such treatment is currently dominated by bone strengthening agents known as antiresorptive therapies, including Merck & Co’s Fosamax, which block the normal process of break down of bone minerals. But they take years to get a substantial benefit.
Romosozumab-aqqg belongs to a new class of drugs known as sclerostin inhibitors.