Tymlos Approved with Black Box Warning
April 28, 2017 – The U.S. Food and Drug Administration (FDA) approved Tymlos (abaloparatide) injection for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture, manufactured by Radius Health. Tymlos is reported to reduce the risk of vertebral and non-vertebral fractures in postmenopausal women with osteoporosis. High-risk factors for bone fracture include a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Along with the approval, the FDA added a black box warning to the treatment, saying that the drug increased the risk of bone cancer in rat experiments. According to the manufacturer, Tymlos will compete with Eli Lilly’s osteoporosis drug Forteo, which has a similar black box warning.
The FDA approved Tymlos based on results at the 18th month of the landmark ACTIVE trial and after 6 months of the ACTIVExtend trial that demonstrated consistent significant and rapid reductions in the risk of vertebral and non-vertebral fractures regardless of age, years since menopause, presence or absence of prior fracture (vertebral or non-vertebral), and bone mineral density (BMD) at baseline.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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