Amgen reports long-term safety data for Prolia

Amgen has announced data from a long-term clinical study that demonstrates the strong safety profile of its osteoporosis therapy Prolia.

Data  from a seven-year open-label extension of its phase III FREEDOM study indicated that treatment with Prolia for up to ten years was associated with a consistent rate of adverse events, with a low fracture incidence.

In addition, postmenopausal women with osteoporosis on Prolia continued to show gains in bone mineral density over ten years, meaning the drug can offer a positive risk-benefit profile.

This adds to a  significant body of evidence generated to inform Prolia's long-term safety, including more than 100 original publications and presentations over the last seven years.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "The evidence from this pivotal phase III fracture trial and its extension highlights the value of Prolia in the treatment of women with postmenopausal osteoporosis at high risk for fracture."

This comes after the firm reported data showing the bone mineral density gains associated with Prolia earlier this week.