FDA Approves Abaloparatide to Treat Men with Osteoporosis & High Risk of Fracture
On Dec. 19, 2022, the U.S. Food & Drug Administration (FDA) approved subcutaneous abaloparatide (Tymlos) for the treatment of men with osteoporosis at high risk of fracture, as well as adult patients for whom other osteoporosis therapies have proved ineffective or can’t tolerate other therapies.1
The FDA had previously approved abaloparatide for the treatment of postmenopausal women with osteoporosis at high risk of fracture.2
Abaloparatide is an analog of parathyroid hormone-related peptide [PTHrP(1-34)].3 High fracture risk is defined as a history of osteoporotic fracture or multiple risk factors for fracture, such as age, low bone mineral density (BMD) and previous fragility fracture.4
This latest FDA approval was based on findings of a 12-month, safety and efficacy study of subcutaneous abaloparatide in men with osteoporosis (ATOM; NCT03512262).5 The multicenter, phase 3 study was randomized and double-blinded.
In the study, researchers evaluated 80 μg of abaloparatide given daily as a subcutaneous injection to men with osteoporosis (n=149) aged 40–85 years old. This group was compared with a group of men with osteoporosis who received placebo injections (n=79). All patients also took daily supplemental calcium (500–1,000 mg) and vitamin D (400–800 IU).
The study’s primary outcome measure was the change in percentage from baseline in BMD of the lumbar spine at month 12. Secondary outcome measures were the change in percentage from baseline in BMD of the total hip and femoral neck at month 12, the change in percentage from baseline in BMD of the lumbar spine at month six and treatment-associated emergent adverse events associated with hypercalcemia within 13 months.
- News release: Radius Health’s Tymlos (abaloparatide) receives U.S. FDA approval as a treatment to increase bone density in men with osteoporosis at high risk for fracture. 2022 Dec 20.
- New drug application approval letter: Tymlos (abaloparatide) injection. 2017 April 28.
- Highlights of prescribing information: Tymlos (abaloparatide) injection for subcutaneous use. U.S. Food & Drug Administration. 19 Dec 2022.
- Patients at high risk of fracture. International Osteoporosis Foundation. 2023.
- Safety and efficacy of abaloparatide-sc in men with osteoporosis (ATOM; NCT03512262). ClinicalTrials.gov. 2021 Nov 8.