The labeling for Tymlos (abaloparatide) has been updated to include additional information regarding the mechanism of action (MOA) of the drug.
Tymlos, a human parathyroid hormone related peptide analogue, is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Tymlos reduces the risk of vertebral fractures and nonvertebral fractures.
The updated MOA section now states that once daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.
The update is based on data from an open-label, single-arm histomorphometry study (ClinicalTrials.gov Identifier: NCT03710889) that included 23 postmenopausal women with osteoporosis. Results showed that following 3 months of daily treatment with abaloparatide, bone formation was observed on cancellous, endocortical, intracortical, and periosteal bone envelopes.
“The histomorphometry study provides the first histologic evidence in humans that abaloparatide stimulates new bone formation, in other words, builds new bone,” said Dr Bruce Mitlak, Chief Medical Officer at Radius Health, Inc.
Tymlos is supplied as a single-patient-use prefilled pen, which delivers 30 doses, each containing 80mcg of abaloparatide in 40mcL of solution.
- Tymlos label and business update. News release. September 22, 2021. https://www.globenewswire.com/news-release/2021/09/22/2301274/31149/en/TYMLOS-Label-and-Business-Update.html.
- Dempster DW, Zhou H, Sudhaker DR, et al. Early effects of abaloparatide on bone formation and resorption indices in postmenopausal women with osteoporosis. Published online January 12, 2021. Journal of Bone and Mineral Research. doi.org/10.1002/jbmr.4243