The Food and Drug Administration (FDA) has approved Tymlos® (abaloparatide) as a treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
The approval was based on data from a randomized, double-blind, placebo-controlled phase 3 study (ClinicalTrials.gov Identifier: NCT03512262) that included men aged 42 to 85 years with baseline mean T-scores of -2.1 at the lumbar spine, -2.1 at the femoral neck, and -1.7 at the total hip. Patients were randomly assigned to receive abaloparatide 80mcg (n=149) or placebo (n=79) administered by subcutaneous injection once daily.
Results showed that treatment with abaloparatide for 12 months resulted in significant increases in bone mineral density compared with placebo at the lumbar spine (primary endpoint; treatment difference, 7.3% [99% CI, 5.1-9.6]; P <.0001), total hip (treatment difference, 2.1% [99% CI, 1.0-3.2]; P <.0001), and femoral neck (treatment difference, 2.8% [99% CI, 1.4-4.2]; P <.0001).
The most common adverse reactions reported in men with osteoporosis treated with abaloparatide were injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, contusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain.
Tymlos, a human parathyroid hormone related peptide [PTHrP(1-34)] analog, is also indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
- Radius Health’s Tymlos® (abaloparatide) receives US FDA approval as a treatment to increase bone density in men with osteoporosis at high risk for fracture. News release. December 20, 2022. https://www.prnewswire.com/news-releases/radius-healths-tymlos-abaloparatide-receives-us-fda-approval-as-a-treatment-to-increase-bone-density-in-men-with-osteoporosis-at-high-risk-for-fracture-301707619.html.
- Tymlos. Package insert. Radius Health, Inc. 2022; Accessed December 20, 2022. https://radiuspharm.com/wp-content/uploads/tymlos/tymlos-prescribing-information.pdf.