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Abaloparatide: First Global Approval.
Drugs. 2017 Aug; 77(12):1363-1368.D

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.

Authors+Show Affiliations

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28624872

Citation

Shirley, Matt. "Abaloparatide: First Global Approval." Drugs, vol. 77, no. 12, 2017, pp. 1363-1368.
Shirley M. Abaloparatide: First Global Approval. Drugs. 2017;77(12):1363-1368.
Shirley, M. (2017). Abaloparatide: First Global Approval. Drugs, 77(12), 1363-1368. https://doi.org/10.1007/s40265-017-0780-7
Shirley M. Abaloparatide: First Global Approval. Drugs. 2017;77(12):1363-1368. PubMed PMID: 28624872.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Abaloparatide: First Global Approval. A1 - Shirley,Matt, PY - 2017/6/19/pubmed PY - 2018/6/2/medline PY - 2017/6/19/entrez SP - 1363 EP - 1368 JF - Drugs JO - Drugs VL - 77 IS - 12 N2 - 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. SN - 1179-1950 UR - https://www.unboundmedicine.com/medline/citation/28624872/Abaloparatide:_First_Global_Approval_ L2 - https://dx.doi.org/10.1007/s40265-017-0780-7 DB - PRIME DP - Unbound Medicine ER -