Amgen Issues Statement About Prolia^® (denosumab) Approval in Australia

Amgen is pleased to announce that it has received Therapeutic Goods Administration (TGA) approval in Australia for Prolia^® (denosumab) for the treatment of osteoporosis in postmenopausal women.ⁱ  This approval comes just days after the Food and Drug Administration (FDA) approved Prolia in the United States and the European Commission (EC) granted marketing authorization for Prolia in the 27 European Union member states.

There remains a significant need for new treatment options for postmenopausal osteoporosis. This silent disease, which usually shows no symptoms until a fracture occursⁱⁱ, affects an estimated 510,000 women in Australiaⁱⁱⁱ with a total cost burden of $7.4 billion per year.^iv In 2009 there were an estimated 76,000 fractures in Australia as a result of osteoporosis.^v

The approval of Prolia in Australia is a significant milestone for the patients for whom Prolia is an important new treatment option. We look forward to offering this first-in-class new medicine in Australia and the other countries in which Prolia is now approved.   

ⁱ Prolia® approved Product Information. June 2010.
ⁱⁱ Australian Institute of Health and Welfare 2008. A picture of osteoporosis in Australia. Arthritis series no. 6. Cat. No. PHE 99. Canberra: AIHW.
ⁱⁱⁱ Australian Institute of Health and Welfare 2008. A picture of osteoporosis in Australia. Arthritis series no. 6. Cat. No. PHE 99. Canberra: AIHW.
^iv Access Economics 2001. The burden of brittle bones: costing osteoporosis in Australia. Canberra: Access Economics.
^v Access Economics 2010. A future less fragile. Canberra: Access Economics.