Amgen Gets CHMP’s Positive Opinion On Prolia

Amgen has received a positive opinion for the marketing authorisation of Prolia (denosumab) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the treatment of osteoporosis in postmenopausal women and bone loss associated with hormone ablation in men with prostate cancer.

The company said that if approved by the European Commission (EC), Amgen would receive marketing authorisation for Prolia in all EU member states. Prolia is also under regulatory review in the US, Switzerland, Australia and Canada for the treatment and prevention of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation therapy for breast or prostate cancer.

Reportedly, the CHMP’s positive opinion is based on data from six phase 3 trials. Two phase 3 pivotal studies with fracture endpoints in the osteoporosis and prostate cancer settings demonstrated that Prolia administered as a subcutaneous injection twice yearly (60mg) reduces the incidence of fractures. All six studies showed Prolia’s ability to increase bone mineral density at all skeletal sites measured.

The results from the pivotal FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study in 7,868 women with postmenopausal osteoporosis, showed that women receiving a subcutaneous injection of Prolia twice-yearly experienced a 68% reduction in the risk of suffering a new vertebral (spine) fracture as well as a 40% reduction in the risk of suffering a hip fracture and a 20% reduction in the risk of suffering a nonvertebral fracture.

Furthermore, the results from the pivotal 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.