Radius Pharmaceuticals unveiled real-world evidence at the recently held World Congress on Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases, demonstrating increased efficacy of Tymlos (abaloparatide) therapy in reducing hip and non-vertebral fractures compared to teriparatide in women aged 50 years and older. Despite positive results, Tymlos will have to face a highly competitive osteoporosis market, according to GlobalData, a leading data and analytics company.
Osteoporosis is a systemic skeletal condition characterized by diminished bone mass and micro-architectural deterioration, rendering individuals susceptible to bone fragility and fractures. Disease progression may precede fractures by years, with over two-thirds of vertebral fractures being painless, complicating early detection.
Sulayman Patel, MSci, Pharma Analyst at GlobalData, comments: “Despite being a prevalent metabolic bone disorder posing a significant threat worldwide, osteoporosis is often overlooked, earning the moniker of a “silent disease”. The challenging nature of osteoporosis underscores the crucial need for effective treatments like Tymlos, which received FDA approval in April 2017 for postmenopausal women at high fracture risk or intolerant to other therapies, boasting proven efficacy in reducing both vertebral and nonvertebral fractures. Tymlos received expanded approval in December 2022 for increasing bone density in high-risk osteoporotic men, further solidifying its position as an effective therapy.”
Administered through a prefilled pen, Tymlos offers a patient-friendly subcutaneous injection option, delivering 80μg per dose over a 30-day period. The comprehensive real-world retrospective observational cohort study, encompassing data from over 43,000 patients, underscored Tymlos’ advantage over teriparatide, with decreased incidence rates of hip and non-vertebral fractures.
Patel continues: “Additionally, the study revealed that Tymlos demonstrated a balanced incidence of major cardiovascular events compared to teriparatide, highlighting an acceptable safety profile.”
This study employed propensity score matching to ensure the robustness and reliability of these findings, which may support physicians when choosing therapies, thereby optimizing pharmacological management for osteoporosis patients.
Patel concludes: “GlobalData analysis indicates the osteoporosis market faces strong competition, with various players offering bisphosphates, selective estrogen receptor modulators, and other therapies such as Evenity (romosozumab), competing for patient share. Further change is expected as more biosimilars enter the market, specifically denosumab biosimilars, which are anticipated to enter the US and European markets in 2024 and 2025, respectively.”