Chemistry:Palopegteriparatide
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|---|---|
| Trade names | Yorvipath |
| Other names | ACP-014, TransCon PTH |
| Routes of administration | Subcutaneous |
| Drug class | Hormonal agent |
| ATC code | |
| Legal status | |
| Legal status | |
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Palopegteriparatide, sold under the brand name Yorvipath, is a hormone replacement therapy used for the treatment of chronic hypoparathyroidism.[1] It is a transiently pegylated parathyroid hormone.[3]
Medical uses
Yorvipath indicated for the treatment of adults with chronic hypoparathyroidism.[1]
Society and culture
Legal status
In September 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yorvipath, intended for the treatment of chronic hypoparathyroidism in adults.[3][4] The applicant for this medicinal product is Ascendis Pharma Bone Diseases A/S.[3] Palopegteriparatide was approved for medical use in the European Union in November 2023.[1]
Palopegteriparatide was granted an orphan drug designation by the US Food and Drug Administration (FDA) in 2018,[5] and by the EMA in 2020.[6]
Brand names
Palopegteriparatide is the international nonproprietary name.[7][8]
Palopegteriparatide is sold under the brand name Yorvipath.[1]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Yorvipath EPAR". 19 October 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/yorvipath. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Yorvipath Product information". 20 November 2023. https://ec.europa.eu/health/documents/community-register/html/h1766.htm.
- ↑ 3.0 3.1 3.2 "Yorvipath: Pending EC decision". 15 September 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/yorvipath. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Ascendis Pharma Receives Positive CHMP Opinion for TransCon PTH (palopegteriparatide) for Adults with Chronic Hypoparathyroidism". Ascendis Pharma (Press release). 14 September 2023. Archived from the original on 24 September 2023. Retrieved 24 September 2023.
- ↑ "TransCon Parathyroid Hormone (mPEG conjugated parathyroid hormone 1-34) Orphan Drug Designations and Approvals". https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=638818.
- ↑ "EU/3/20/2350". 15 September 2023. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2350.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86". WHO Drug Information 35 (3). 2021.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 89". WHO Drug Information 37 (1). 2023.
External links
- Palopegteriparatide Global Substance Registration System
- Palopegteriparatide NCI Thesaurus
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