Palopegteriparatide

Palopegteriparatide, is an investigational medication designed for the treatment of chronic hypoparathyroidism.[1] It is a transiently pegylated parathyroid hormone.[1]

Palopegteriparatide
Clinical data
Other namesACP-014, TransCon PTH
Drug classHormonal agent
ATC code
  • None
Identifiers
CAS Number
UNII
KEGG

Society and culture

Names

Palopegteriparatide is the international nonproprietary name.[2][3]

On 14 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.[1][4] The applicant for this medicinal product is Ascendis Pharma Bone Diseases A/S.[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]

References
  1. "Yorvipath: Pending EC decision". European Medicines Agency. 15 September 2023. Archived from the original on 24 September 2023. Retrieved 24 September 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86". WHO Drug Information. 35 (3). hdl:10665/346562.
  3. World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 89". WHO Drug Information. 37 (1). hdl:10665/366661.
  4. "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.
  5. "TransCon Parathyroid Hormone (mPEG conjugated parathyroid hormone 1-34) Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Archived from the original on 24 September 2023. Retrieved 24 September 2023.
  6. "EU/3/20/2350". European Medicines Agency. 15 September 2023. Archived from the original on 24 September 2023. Retrieved 24 September 2023.


This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.