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Abaloparatide: First Global Approval

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Abstract

Abaloparatide (Tymlos™) is a synthetic peptide analogue of human parathyroid hormone-related protein that was developed by Radius Health as an osteoanabolic agent for the treatment of postmenopausal osteoporosis. Abaloparatide acts through selective activation of the parathyroid hormone type 1 receptor signalling pathway. In April 2017, subcutaneous abaloparatide received its first global approval, in the USA, 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. A Marketing Authorization Application for subcutaneous abaloparatide for the treatment of postmenopausal women with osteoporosis was accepted by the European Medicines Agency and is currently under review. Radius is also developing a transdermal formulation of abaloparatide, with administration via a microneedle patch. This article summarizes the milestones in the development of abaloparatide leading to this first approval for the treatment of women with postmenopausal osteoporosis.

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References

  1. US FDA. Tymlos™ (abaloparatide) injection, for subcutaneous use: US prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf. Accessed 30 May 2017.

  2. Culler MD, Dong J, Shen Y, et al. BIM-44058, a novel analog of PTHrP with enhanced bone building activity, but decreased calcium-mobilization potential [abstract no. M460]. J Bone Miner Res. 2001;16(Suppl 1):M460.

    Google Scholar 

  3. Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316(7):722–33.

    Article  CAS  PubMed  Google Scholar 

  4. Hattersley G, Dean T, Corbin BA, et al. Binding selectivity of abaloparatide for PTH-type-1-receptor conformations and effects on downstream signaling. Endocrinology. 2016;157(1):141–9.

    Article  CAS  PubMed  Google Scholar 

  5. US FDA. Novel drug approvals for 2017. 2017. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm. Accessed 30 May 2017.

  6. Radius Health. Radius announces European Medicines Agency validates Marketing Authorization Application for abaloparatide-SC for the treatment of osteoporosis in postmenopausal women [media release]. 2015. http://investors.radiuspharm.com/releasedetail.cfm?ReleaseID=945612. Accessed 30 May 2017.

  7. Jolette J, Attalla B, Varela A, et al. Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1–34). Regul Toxicol Pharmacol. 2017;86:356–65.

    Article  CAS  PubMed  Google Scholar 

  8. Radius Health. Radius announces positive top-line results from completed ACTIVExtend study for TYMLOS™ in postmenopausal women with osteoporosis [media release]. 2017. http://investors.radiuspharm.com/releasedetail.cfm?ReleaseID=1027778. Accessed 30 May 2017.

  9. Radius Health. Radius, 3M Drug Delivery Systems announce exclusive agreement for development, commercialization of transdermal delivery of BA058 for osteoporosis [media release]. 2012. http://investors.radiuspharm.com/releasedetail.cfm?ReleaseID=838112. Accessed 30 May 2017.

  10. Leder BZ, O’Dea LS, Zanchetta JR, et al. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015;100(2):697–706.

    Article  CAS  PubMed  Google Scholar 

  11. Moreira CA, Fitzpatrick LA, Wang Y, et al. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: the ACTIVE phase 3 trial. Bone. 2017;97:314–9.

    Article  CAS  PubMed  Google Scholar 

  12. Varela A, Chouinard L, Lesage E, et al. One year of abaloparatide, a selective peptide activator of the PTH1 receptor, increased bone mass and strength in ovariectomized rats. Bone. 2017;95:143–50.

    Article  CAS  PubMed  Google Scholar 

  13. Varela A, Chouinard L, Lesage E, et al. One year of abaloparatide, a selective activator of the PTH1 receptor, increased bone formation and bone mass in osteopenic ovariectomized rats without increasing bone resorption. J Bone Miner Res. 2017;32(1):24–33.

    Article  CAS  PubMed  Google Scholar 

  14. Bahar H, Gallacher K, Downall J, et al. Six weeks of daily abaloparatide treatment increased vertebral and femoral bone mineral density, microarchitecture and strength in ovariectomized osteopenic rats. Calcif Tissue Int. 2016;99(5):489–99.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Cosman F, Miller PD, Williams GC, et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial. Mayo Clin Proc. 2017;92(2):200–10.

    Article  CAS  PubMed  Google Scholar 

  16. Cosman F, Hattersley G, Hu MY, et al. Effects of abaloparatide-SC on fractures and bone mineral density in subgroups of postmenopausal women with osteoporosis and varying baseline risk factors. J Bone Miner Res. 2017;32(1):17–23.

    Article  CAS  PubMed  Google Scholar 

  17. Saeh J, Pais D, Hamad E, et al. Clinical development of an optimized abaloparatide transdermal patch [abstract no. LB-1162]. In: 38th annual meeting of the American Society for Bone and Mineral Research. 2016.

  18. Radius Health. Radius Health reports first quarter 2017 financial and operating results [media release]. 2017. http://investors.radiuspharm.com/releasedetail.cfm?ReleaseID=1023647. Accessed 30 May 2017.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. M. Shirley is a salaried employee of Adis, Springer SBM.

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  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Matt Shirley

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  1. Matt Shirley
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Correspondence to Matt Shirley.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Shirley, M. Abaloparatide: First Global Approval. Drugs 77, 1363–1368 (2017). https://doi.org/10.1007/s40265-017-0780-7

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