Health and Healthcare

Amgen Wins Another FDA Approval

Chris Lange

Published: May 22, 2018 11:40 am

Last Updated: January 11, 2020 11:18 pm

Amgen Inc. (NASDAQ: AMGN) shares made a slight gain on Tuesday after it was announced that the U.S. Food and Drug Administration (FDA) approved its treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture. Specifically, the agency approved Prolia (denosumab), driven by positive late-stage results.

This approval is based on data from a Phase 3 study that showed patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density (BMD) compared to those who received active comparator (risedronate).

Study results showed that Prolia demonstrated a significantly greater increase in lumbar spine BMD in the glucocorticoid-continuing subpopulation, compared to risedronate at one year (3.8% versus 0.8%, respectively). Similarly, in the glucocorticoid-initiating subpopulation, Prolia demonstrated a significantly greater increase in lumbar spine BMD compared to risedronate at one year (4.4% versus 2.3%, respectively).

Also, safety results were consistent with the known safety profile of Prolia.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, commented:

As a leader in bone health with more than 20 years of osteoporosis research experience, we are pleased that Prolia will now be available for patients at high risk of fracture who are suffering from bone loss due to long-term glucocorticoid treatment. This is a serious condition that leads to rapid decreases in bone mineral density and increased risk of fracture. This approval gives patients and physicians a new treatment option.

Shares of Amgen were last seen up about 1% at $178.54, with a consensus analyst price target of $195.14 and a 52-week range of $152.16 to $201.23.

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