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FDA Approves Romosozumab for Post-menopausal Osteoporosis

April 11, 2019
Evenity lowered vertebrae fractures risks in two trials

A PPM Brief

FDA has approved romosozumab (brand name Evenity) to treat osteoporosis in postmenopausal women at high risk of fracture, with a history of osteoporotic fracture, or those who have failed or are intolerant to other osteoporosis therapies.

Evenity (Amgen, Thousand Oaks, CA) is a monoclonal antibody that blocks the effects of the protein sclerostin and increases new bone formation. One dose of Evenity involves two injections, given one month one after the other. The bone forming effect of Evenity wanes after 12 doses, and FDA warns that no more than 12 doses should be used. If osteoporosis therapy is still needed after treatment, reduction of bone breakdown should be the focus, according to FDA.

Evenity lowered vertebrae fractures risks in two trials. (Source: 123RF)

Evenity’s safety and efficacy was demonstrated in two clinical trials involving more than 11,000 women with post-menopausal osteoporosis:

  • The first trial of Evenity lowered the risk of a vertebral fracture by 73% compared to placebo after 1 year of treatment. This was maintained over a second year when Evenity was followed by 1 year of denosumab (another osteoporosis therapy), compared to placebo followed by denosumab.
  • In the second trial, 1 year of treatment with Evenity followed by one year of alendronate (another osteoporosis therapy) reduced the risk of a new vertebral fracture by 50% compared to 2 years of alendronate alone. Evenity followed by alendronate also reduced the risk of fractures in other bones (nonvertebral fractures) compared to alendronate alone.

In the second trial, Evenity increased the risk of cardiovascular death, heart attack, and stroke. Therefore, Evenity contains a boxed warning on its labeling and should not be used in patients who have had a heart attack or stroke within the previous year. FDA advises that clinicians be cautious in prescribing Evenity in those with risk factors for heart disease, and should discontinue its treatment for any patient who experiences a heart attack or stroke.

Common side effects of Evenity are joint pain, headache, and injection site reactions.

Last updated on: May 3, 2019
Continue Reading:
Chronic Pain, Osteoporosis, and Bone Density Testing
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