See the DrugPatentWatch profile for Tymlos
Tymlos (abaloparatide) is a bone-forming drug used for the treatment of postmenopausal women with osteoporosis at high risk for fracture [1].
What are the key clinical trial findings for Tymlos?
Clinical trials have demonstrated Tymlos's efficacy in reducing the risk of fractures. In the Active-Controlled Efficacy Study in Fractured Postmenopausal Women With Osteoporosis (াবলoparatide Versus Teriparatide in Postmenopausal Women With Osteoporosis) trial, Tymlos reduced the incidence of new vertebral fractures by 81% compared to placebo [2]. It also showed a significant reduction in non-vertebral fractures and clinical fractures [2]. The trial followed women for a median of 18 months [2].
How long does Tymlos treatment last?
The typical duration of Tymlos treatment is 24 months [1]. Extended use beyond this period has not been studied [1].
What is the mechanism of action for Tymlos?
Tymlos is a parathyroid hormone-related peptide (PTHrP) analog [1]. It works by stimulating osteoblasts, which are bone-building cells, leading to increased bone formation [1]. This anabolic effect helps to improve bone mineral density and reduce fracture risk [1].
What are the risks associated with Tymlos?
Potential risks associated with Tymlos include osteosarcoma, a type of bone cancer, which has been observed in rats [1][3]. While the risk in humans is considered low, it is a contraindication for patients with a history of osteosarcoma or Paget's disease of bone [1][3]. Other risks include hypercalcemia and an increased risk of urinary tract calculi and urinary tract infections [1].
How does Tymlos compare to other osteoporosis medications?
Tymlos is an anabolic agent, meaning it builds bone, unlike antiresorptive drugs such as bisphosphonates which slow bone loss [1]. It is also compared to teriparatide (Forteo), another anabolic agent. Clinical trials have shown Tymlos to be at least as effective as teriparatide in reducing vertebral fractures [2].
When is Tymlos expected to be off-patent?
Information regarding Tymlos's patent exclusivity and potential generic entry can be found on DrugPatentWatch.com [4].
What patient populations is Tymlos approved for?
Tymlos is approved for postmenopausal women with osteoporosis who are at high risk for fracture [1]. This includes women with a history of osteoporotic fracture or multiple risk factors for fracture [1].
Are there any ongoing clinical trials for Tymlos?
Information on ongoing clinical trials for Tymlos can be accessed through clinical trial registries [5].
What is the prescribing information for Tymlos?
Full prescribing information, including dosage, administration, warnings, and precautions, is available from the manufacturer and regulatory agencies [1].
What are the side effects patients should be aware of?
Common side effects reported in clinical trials include hypercalcemia, nausea, and contusion [1]. As mentioned, a rare but serious risk is osteosarcoma [1][3].
What are the regulatory approvals for Tymlos?
Tymlos received FDA approval in April 2017 [1].
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**Sources
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208073Orig1s000Lbl.pdf
[2] https://www.nejm.org/doi/full/10.1056/NEJMoa1510250
[3] https://www.drugpatentwatch.com/en/drug/abaloparatide
[4] https://www.drugpatentwatch.com/
[5] https://clinicaltrials.gov/