Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

"Today's positive opinion by the CHMP is an important step for Prolia in helping patients suffering from bone loss associated with systemic glucocorticoid therapy," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Chronic use of oralglucocorticoids has been associated with an increase in spine and hip fractures, and, if approved, an expanded use of Prolia will provide patients and physicians across much of Europe with a new treatment option for this serious condition."

Glucocorticoid medications, which are used to treat many inflammatory conditions such as chronic obstructive pulmonary disorder (COPD), asthma, multiple sclerosis and rheumatoid arthritis, can cause significant side effects, including bone loss.

The CHMP recommendation is supported by a Phase 3 randomised, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment. The study included two patient groups: those on sustained glucocorticoid therapy and those newly initiating glucocorticoid therapy. The study met the primary endpoint (per cent change from baseline in lumbar spine bone mass density [BMD] at 12 months, assessing non-inferiority) and all secondary endpoints (the per cent changes from baseline in lumbar spine and total hip BMD at 12 and 24 months, assessing superiority). Study results showed that, in patients on sustained glucocorticoid therapy, Prolia treatment led to greater gains in BMD, compared with risedronate, both at the lumbar spine (4.4 per cent versus 2.3 per cent, respectively) and total hip (2.1 per cent versus 0.6 per cent, respectively). Similarly, in patients newly initiating glucocorticoid therapy, Prolia treatment led to greater increases in BMD, compared with risedronate, both at the lumbar spine (3.8 per cent versus 0.8 per cent, respectively) and total hip (1.7 per cent versus 0.2 per cent, respectively).

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the decision of the EC.

The US Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application for this expanded indication and has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.

Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts). Prolia is approved and marketed in over 80 countries worldwide.

Prolia is approved in the US for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.