Amgen reports positive clinical data for osteoporosis drug Prolia

Amgen has announced new phase III clinical trial data further supporting the benefits of its osteoporosis drug Prolia.

Positive top-line results have been announced from a primary analysis of a phase III trial evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.

A total of 795 patients were enrolled in the 24-month study, which aimed to assess the performance of Prolia administered subcutaneously every six months among patients receiving continuing glucocorticoid therapy and those who had newly initiated treatment.

The study met all primary and secondary endpoints at 12 months, with Prolia shown to be associated with significantly greater gains in bone mineral density at the lumbar spine and total hip.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are excited that these data support the potential for Prolia use in patients with glucocorticoid-induced osteoporosis, the most common drug-induced form of the disease."

Prolia is approved and marketed in over 80 countries worldwide, including the EU, for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures.

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