Nearly two months ahead of schedule, the U.S. Food and Drug Administration has approved Amgen Inc.’s new drug Prolia to treat osteoporosis in postmenopausal women at high risk for fractures, the agency said late Tuesday.

“Amgen … is delighted that the FDA has announced this approval ahead of the targeted action date of July 25,” the Thousand Oaks biotech said in a statement.

Amgen also is hoping to get Prolia, also known as denosumab, approved for additional uses in the United States. European regulators last week approved the drug both for postmenopausal women, and for men with prostate cancer who are at risk of fractures because hormone treatments for their cancer.

In addition, Amgen has submitted clinical trial studies to support its claim that Prolia may reduce the potential for fractures and other skeletal-related problems in cases where a patient’s cancer has spread to the bone, a potentially large market for the drug. The data will be discussed at a major oncology meeting this weekend.

The drug’s approval was based on a three-year late-stage study involving 7,808 postmenopausal women with osteoporosis. Prolia works by inhibiting proteins that feed bone-destroying cells, and is the first drug to fight osteoporosis in this manner. It is administered every six months as an under-the-skin injection.

Prolia will be available to the public with a week, Amgen said. It’s wholesale price will be $825 per 60-mg injection, competitive with other branded osteoporosis therapies.

The FDA approved Prolia with the requirement that Amgen implement a risk evaluation and mitigation strategy that includes medication guides for doctors and patients explaining the risks and benefits of the drug. The agency has become more cautious about newly approved drugs in the wake of several high-profile cases of new drugs – including Amgen’s own anemia drug Aranesp — later being found to increase the risk for death and other severe side-effects in certain cases.

If a success, Prolia’s revenue could help make up for Aranesp sales lost in the last few years since the FDA put tighter restrictions on its use.

Amgen shares on Wednesday jumped $5.33, or 10.5 percent to $56.09 on the Nasdaq.