Radius Pharmaceuticals presented real-world evidence at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases on 12 April 2024, demonstrating that Tymlos therapy resulted in a lower incidence of hip and nonvertebral fractures compared to teriparatide therapy in women with osteoporosis aged 50 and older.
The analysis was based on over 18 months of treatment data involving 43,352 patients, and highlighted Tymlos’ efficacy and safety profile as an important treatment option for osteoporosis management.
Despite limitations in the real-world evidence, the study supported Tymlos’ value in reducing fracture risk, further solidifying its role in addressing osteoporosis.
Osteoporosis stands as the prevailing metabolic bone disorder globally, and is the primary cause of fragility fractures.
It manifests as a systemic skeletal condition characterised by reduced bone mass and the deterioration of bone structure, increasing susceptibility to fractures, particularly in the spine, hip, distal forearm, and proximal humerus.
These fractures significantly contribute to morbidity, often requiring prolonged recovery and full-time care for many patients.
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By GlobalData
Additionally, hip fractures in particular are associated with increased mortality rates.
Despite its impact, osteoporosis is commonly overlooked as the disease often presents itself only after a fracture, and as such, osteoporosis is deemed a ‘silent disease’.
The development of osteoporosis typically extends several years before it results in a fracture, often prompting medical attention.
Notably, more than 66% of vertebral fractures occur without pain, complicating early detection.
Prominent symptoms include back pain from fractured vertebrae, which can lead to visible deformity or reduced mobility.
Additionally, the condition can lead to stooped posture, known as kyphosis, as vertebral fractures cause the spine to collapse and bend forward, further impacting the individual’s physical functionality and quality of life.
Tymlos received approval from the US Food and Drug Administration (FDA) in April 2017 as a treatment for postmenopausal women facing osteoporosis with a high risk of fractures or those who could not tolerate other therapies.
Its efficacy in reducing the risk of both vertebral and nonvertebral fractures has been well-established in this demographic.
In December 2022, Tymlos garnered further FDA approval for enhancing bone density in men diagnosed with osteoporosis who were at high risk of fractures.
Administered through a prefilled pen, Tymlos delivers 80 micrograms per dose subcutaneously over a 30-day period, offering a convenient and effective treatment option for individuals who are at risk of osteoporotic fractures.
Over an 18-month treatment period, the study revealed notable differences in fracture incidence between the two cohorts.
Tymlos exhibited a significantly lower occurrence of both hip and nonvertebral fractures compared to teriparatide.
Specifically, hip fractures were reported in 1.1% of women in the Tymlos cohort compared to 1.4% in the teriparatide cohort, with similar trends observed for nonvertebral fractures.
Importantly, the incidence of major cardiovascular events remained balanced between the two treatment groups, emphasising the comparative safety profiles of the therapies.
This real-world retrospective observational cohort study focused on women aged 50 and older who were newly prescribed anabolic therapy with either Tymlos or teriparatide between May 2017 and December 2021.
Employing propensity score matching, the analysis ensured a balance of 73 baseline parameters between the treatment groups, enhancing the reliability of the findings.
Data was sourced from Symphony Health Patient Source, Osteoporosis Patient Transactional Datasets, which is an osteoporosis-specific subset from the Integrated Dataverse, including data from more than 307 million active patients.
Key opinion leaders (KOLs) interviewed by leading data and analytics company GlobalData have provided positive opinions regarding Tymlos as a therapy choice for patients with osteoporosis.
For example, a top Japanese KOL described Tymlos as “easier to use”, “better”, and “more effective” than teriparatide based on clinical experience.
While this data is promising, the osteoporosis therapy market is competitive, and Tymlos will have to compete with several drugs, including oral and intravenous bisphosphonates, denosumab, selective estrogen receptor modulators, and hormone replacement therapy.
This competition for patient share has been accelerated by the appearance of teriparatide biosimilars and the latest innovative therapy, Amgen’s Evenity.
The osteoporosis market is set to face substantial change as further biosimilars enter the market, particularly denosumab biosimilars, which are expected to launch in the US and European markets in 2024 and 2025, respectively.
Further change is expected as physicians and patients become more comfortable with newer therapies such as Evenity.