New osteoporosis medication romosozumab approved in the US

The new osteoporosis medication romosozumab has been approved for use in the US by the Food and Drug Administration (FDA) this week in postmenopausal women who are high risk of breaking a bone, or those who have failed or are intolerant to other osteoporosis therapies.

Romosozumab works to reduce the risk of fracture by blocking the effects of the protein sclerostin and increasing the formation of new bone.

The FDA’s decision to approve romosozumab was based on safety and efficacy data from two clinical trials, involving more than 11,000 women with postmenopausal osteoporosis.

In the first trial, one year of romosozumab treatment lowered the risk of new vertebral fractures by 73 percent. This benefit was maintained over a second year of the trial, where treatment was followed by denosumab for one year.

In the second trial, one year of romosozumab treatment was followed by a year of treatment with alendronate. This was shown to reduce the risk of new vertebral fractures by 50 percent when compared to two years of treatment with alendronate alone. This treatment was also shown to reduce the risk of other fractures.

Use of the medication should be decided on a case-by-case basis, reminded Hylton V. Joffe, Director of the Centre for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products:

“[Romosozumab] may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year.”

Approval of the medication in the US is a positive indication that romosozumab may be approved for use in the UK later in the year.

Professor Neil Gittoes, Chair of our Clinical and Scientific Committee, says:

“It is exciting to at last see this positive news about romosozumab that offers an entirely different approach to treating osteoporosis and preventing fractures.

“Romosozumab is an innovative and highly effective drug that will benefit many patients, particularly those with very high risk of fracture.

“If romosozumab is approved for use in the UK, this will provide a powerful additional therapy that will allow us to more finely tune and align our therapies for patients with osteoporosis. The drug gaining approval in the US is a good first step.”