Amgen’s Prolia Gains EU Approval

Amgen has received approval from the EMEA for Prolia (denosumab) for osteoporosis. The drug’s initial indication will be for women with post-menopausal osteoporosis and men with prostate cancer who, as a result of hormone therapy, are at increased risk of bone fractures.

Prolia is administered every six months by injection and is the first in a new class of drugs designed to inhibit proteins that activate bone-destroying cells. The drug is currently under review by the FDA and a decision is expected by late July.

The drug is also being developed for expanded use in cancer patients.
Amgen and GlaxoSmithKline will collaborate to commercialize the drug in Europe for osteoporosis, while Amgen will retain full rights for North America and for oncology indications in Europe. GSK will be responsible for sales in emerging markets.