The CHMP has issued a recommendation supporting the use of Prolia (denosumab) to treat osteoporosis in postmenopausal women at increased risk of fractures, and men with prostate cancer undergoing hormone ablation therapy.

If the drug is approved by the European Commission, manufacturer Amgen would receive marketing authorisation for Prolia in all EU Member States.

“Nearly two decades ago, Amgen researchers described a fundamental biochemical pathway that controls bone remodelling,” said Roger M. Perlmutter, Executive Vice President of Research and Development at Amgen. “Armed with this information, our scientists identified a targeted therapy that acts via this normal control mechanism to reduce bone loss.

“With its ability to significantly reduce fractures at key skeletal sites throughout the body, a favourable benefit-risk profile, and convenient dosing every six months, Prolia addresses an important unmet medical need.”

The CHMP positive opinion was based on data from six Phase 3 trials that showed Prolia’s ability to increase bone mineral density. Two studies in osteoporosis and prostate cancer demonstrated that Prolia reduced the incidence of fractures when administered as a subcutaneous injection twice-yearly.

The FREEDOM study in 7,868 women with postmenopausal osteoporosis showed that those receiving Prolia experienced a 68% reduction in the risk of suffering a new vertebral (spine) fracture, compared to those receiving placebo. This group also had a 40% reduction in the risk of a hip fracture and a 20% reduction in the risk of a non-vertebral fracture.

The Hormone AbLation Therapy study in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed that patients treated with Prolia experienced a 62% reduction in the risk of suffering a new vertebral fracture compared to placebo at 36 months.

Prolia is also under regulatory review in the US, Switzerland, Australia and Canada in a similar indication.

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