FDA Approves Prolia, Amgen's New Osteoporosis Drug

Posted on June 4, 2010

Reuters reports that the U.S. Food and Drug Administration (FDA) has approved Prolia, a new osteoporosis drug from Amgen, Inc. The drug is designed to prvent fractures in post-menopausal women. Reuters says the drug just received European approval days ago.

"Denosumab is the most potent agent ever introduced into clinical practice that blocks bone degradation," Roger Perlmutter, Amgen's research chief, said in a telephone interview.
Analysts estimate the product could see annual global sales of $3.3 billion in 2014 for the world's biggest biotechnology company, according to Thomson Reuters data.
"Most of us certainly expected this drug to be approved," said Cowen and Co analyst Eric Schmidt, adding it was "a surprise that it happened before" July 25.

WedMD reports that Prolia is meant for three types of patients.

Postmenopausal women with osteoporosis and high risk of fracture (that is, previous fracture due to osteoporosis or multiple fracture risk factors).
Patients with osteoporosis for whom other osteoporosis treatments have failed.
Patients who cannot tolerate other osteoporosis treatments.

WebMD also says Prolia's approval followed three years of clinical trials that showed postmenopausal women taking the drug increased bone density and had fewer fractures.

The drug requires one injection every six months. Prolioa costs $825 per injection, which is $1,650 per year. The drug is expected to be available as early as next week.

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