Third Indication cleared in Europe for Prolia

8 June 2018

The European Commission (EC) has approved a new indication for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

This is the third indication approved in Europe for osteoporosis drug Prolia, says the drug’s developer, biotech major Amgen (Nasdaq: AMGN). It has five indications in the USA, the latest being Food and Drug Administration approval for the treatment of osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy in men and women at high risk of fracture on May 18, 2018.

Prolia generated revenues of $494 million for Amgen in the first quarter of this year.

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