NPR logo Amgen Wins Approval For Twice-A-Year Osteoporosis Drug

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Amgen Wins Approval For Twice-A-Year Osteoporosis Drug

Does the world need another medicine to treat weakened bones of women after menopause?

We're about to find out. The Food and Drug Administration just approved Prolia, a twice-a-year injection made by Amgen, for the treatment of osteoporosis.

As you'd expect, the new medicine beat placebo in reducing fractures in the more than 7,000 post-menopausal women who took part in the clinical tests that FDA reviewed in approving the drug.

Prolia, for what it's worth, is a new type of osteporosis drug — an antibody that blocks the formation of naturally occurring cells in the body that degrade bone.

An earlier test comparing Prolia, known generically as denosumab, with the popular osteoporosis pill Fosamax, or alendronate, gave a slight edge on bone-strengthening to Prolia. Side effects were similar.

Beside the fact that Prolia is injected and Fosamax is swallowed, price could be a factor. Amgen expects to charge about $825 a shot wholesale for Prolia, or $1650 for a year's treatment. Once-a-week Fosamax is now generic, and a year's treatment can be had for around $400, based on the price for a monthly pack at drugstore.com.

Merck's Fosamax became one of the best-selling brand-name drugs in the world. NPR's Alix Spiegel explained last year how the big sales breakthrough for the medicine came when doctors began to diagnose and treat "osteopenia," a slight thinning of bones that is milder than osteoporosis.

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