Amgen Inc. on Friday said its new drug Prolia has been approved in Europe as a treatment for osteoporosis for both women and men in certain circumstances. It’s the first approval for the drug worldwide.
The European Commission, the European Union’s version of the U.S. Food and Drug Administration, approved Prolia for the treatment of osteoporosis in postmenopausal women at increased risk of bone fractures. It also was approved for use by men with prostate cancer who are at risk of fractures because of hormone treatments for their cancer.
The FDA is expected by late July to make its decision on U.S. use of Prolia, also known as denosumab. If approved on time, the drug potentially could reach $3.3 billion in global sales by 2014, according to analyst estimates.
In Europe, Amgen has an agreement with GlaxoSmithKline to serve as its marketing partner for Prolia. The drug is administered every six months as an under-the-skin injection. It works by inhibiting proteins that feed bone-destroying cells, and is the first drug to fight osteoporosis in this manner.
The EU approval was expected because an advisory board had endorsed the drug in December.
"The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, Amgen’s international chief medical officer, in a statement.
In addition to the uses approved in Europe, Amgen is asking U.S. regulators to approve Prolia for reduction of fractures and other bone problems in patients with advanced cancer. The company will present clinical studies backing this use at a major cancer meeting next weekend.
Amgen shares were up 62 cents, or 1 percent, to $52.05 in midday trading on the Nasdaq. Amgen is based in Thousand Oaks.
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