WASHINGTON (Reuters) ? U.S. drug regulators approved two new uses for Amgen Inc's osteoporosis drug Prolia, allowing it to be used for bone loss associated with certain cancer treatments.
The Food and Drug Administration on Monday approved Prolia for the treatment of bone loss in women with breast cancer and in certain men with non-metastatic prostate cancer, making it the first drug for cancer treatment-induced bone loss.
Prolia was approved in 2010 to treat osteoporosis in post-menopausal women who have an increased risk of fractures.
The new indication allows it to be used in women receiving adjuvant aromatase inhibitor therapy for breast cancer and in men with prostate cancer who are being treated with hormone therapy.
Both types of treatment reduce hormone levels, leading to bone loss and an increased risk of fracture.
Shares of Amgen were down 0.5 percent in morning trade on Nasdaq, outperforming the Arca Pharmaceutical Index, which was down 1.7 percent.
Sales of Prolia were $44 million in the second quarter this year, up from $27 million in the first quarter.
Prolia has the same active ingredient, denosumab, as the Amgen drug Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.
Denosumab is the first in a new class of medicines that work by blocking a protein that activates bone-destroying cells called osteoclasts.
(Reporting by Anna Yukhananov; editing by John Wallace)
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