FDA approves Amgen, UCB's postmenopausal osteoporosis drug Evenity

The FDA announced Tuesday that it approved Amgen and partner UCB's Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of fracture. The approval "represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months," said David Reese, executive vice president of R&D at Amgen.

Approval of the sclerostin inhibitor was supported by data from two late-stage studies involving more than 11 000 women. In the FRAME study, Evenity reduced the frequency of new vertebral fractures after 12 months by a significant 73 percent versus placebo, with the benefit maintained over the second year of the trial when Evenity was followed by one year of Amgen's Prolia (denosumab), compared to placebo followed by Prolia. In the ARCH trial, 12 months of treatment with Evenity followed by 12 months of Merck & Co.'s Fosamax (alendronate) was associated with a significant 50-percent lower risk of new vertebral fracture, compared to two years of Fosamax alone, as well as a reduced risk of non-vertebral fractures. However, Evenity was linked to higher rates of serious cardiovascular events versus Fosamax. 

An FDA advisory committee backed approval of Evenity in January (for additional analysis, see ViewPoints: Evenity's hopes in US just got a boost from unlikely source). Amgen and UCB resubmitted the drug for approval last July after the agency had rejected the treatment in 2017 following the release of the ARCH trial data showing the higher rate of serious cardiovascular events. 

Evenity will carry a boxed warning that it may increase the risk of heart attack, stroke and cardiovascular death, and that it is not recommended for patients who experienced a heart attack or stroke in the previous year. The companies are also required to conduct a post-marketing study to assess cardiovascular risks. The FDA noted that "the bone forming effect of Evenity wanes after 12 doses, so more than 12 doses should not be used."

Amgen indicated that the drug, administered via monthly injections by a healthcare provider, will be launched next week, with pricing unveiled at that time. Commenting on the news, William Blair analyst Matt Phipps anticipates slow demand initially because of cardiovascular concerns, while peak sales are expected to reach $500 million. 

Evenity was previously cleared for the treatment of osteoporosis in patients at high risk of fracture in Japan, where the therapy, formerly known as AMG 785, is partnered with Astellas. 

For related analysis, read KOL Views Results: Evenity likely to carve out sizable niche, says leading osteoporosis specialist, and KOL Views Results: Evenity offers some unique features among PMO anabolics, according to leading osteoporosis trialist.

By: Joe Barber

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