FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture
The U.S. Food and Drug
Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in
postmenopausal women at high risk of breaking a bone (fracture). These are
women with a history of osteoporotic fracture or multiple risk factors for
fracture, or those who have failed or are intolerant to other osteoporosis
therapies.
More than 10 million
people in the U.S. have osteoporosis, which is most common in women who have
gone through menopause. People with osteoporosis have weakened bones that are
more likely to fracture.
“Today’s approval
provides women with postmenopausal osteoporosis who are at high risk of
fracture with a new treatment that will reduce this risk,” said Hylton V.
Joffe, M.D, M.M.Sc., director of the Center for Drug Evaluation and Research’s
Division of Bone, Reproductive and Urologic Products. “But Evenity 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.”
Evenity is a
monoclonal antibody that blocks the effects of the protein sclerostin and works
mainly by increasing new bone formation. One dose of Evenity consists of two
injections, one immediately following the other, given once a month by a health
care professional. The bone forming effect of Evenity wanes after 12 doses so
more than 12 doses should not be used. If osteoporosis therapy is needed after
the 12 doses, patients should begin an osteoporosis treatment that reduces bone
breakdown.
The safety and
efficacy of Evenity were demonstrated in two clinical trials involving a total
of more than 11,000 women with postmenopausal osteoporosis. In the first trial,
one year of treatment with Evenity lowered the risk of a new fracture in the
spine (vertebral fracture) by 73% compared to placebo. This benefit was
maintained over the second year of the trial when Evenity was followed by one
year of denosumab (another osteoporosis therapy) compared to placebo followed
by denosumab. In the second trial, one 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 two years of alendronate alone.
Evenity followed by alendronate also reduced the risk of fractures in other
bones (nonvertebral fractures) compared to alendronate alone.
Evenity increased the
risk of cardiovascular death, heart attack and stroke in the alendronate trial,
but not in the placebo trial. Therefore, Evenity contains a boxed warning on
its labeling stating that it may increase the risk of heart attack, stroke and
cardiovascular death and should not be used in patients who have had a heart
attack or stroke within the previous year. Health care professionals should
also consider whether the benefits of Evenity outweigh its risks in those with
other risk factors for heart disease and should discontinue Evenity in any
patient who experiences a heart attack or stroke during treatment.
Common side effects of
Evenity included joint pain and headache. Injection site reactions were also
observed.
The FDA granted the
approval of Evenity to Amgen.
The FDA, an agency
within the U.S. Department of Health and Human Services, protects the public
health by assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human use, and
medical devices. The agency is also responsible for the safety and security of
our nation’s food supply, cosmetics, dietary supplements, products that give
off electronic radiation, and for regulating tobacco products. at high risk of
breaking a bone (fracture). These are women with a history of osteoporotic
fracture or multiple risk factors for fracture, or those who have failed or are
intolerant to other osteoporosis therapies.
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