Biology:Lonapegsomatropin
From HandWiki
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| Trade names | Skytrofa |
| Other names | Lonapegsomatropin-tcgd; rhGH-PEG; ACP-011; ΤransConPEG hGh; WHO-10598 |
| License data | |
| Routes of administration | Subcutaneous injection |
| Drug class | Growth hormone receptor agonist |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem SID | |
| DrugBank | |
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| Chemical and physical data | |
| Formula | C1051H1627N269O317S9[C2H4O]4n |
Lonapegsomatropin, sold under the brand name Skytrofa, is a human growth hormone used for the treatment of growth hormone deficiency.[1][3] Lonapegsomatropin is a prodrug of somatropin.[1]
Lonapegsomatropin was approved for medical use in the United States in August 2021,[1][2][5] and in the European Union in January 2022.[3]
Medical uses
Lonapegsomatropin is a growth hormone therapy indicated to treat growth hormone deficiency.[1][3]
History
The US Food and Drug Administration granted the application for lonapegsomatropin orphan drug designation.[6]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9229f871-bc61-4ddc-8122-d126d40e36ac.
- ↑ 2.0 2.1 "Skytrofa: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761177.
- ↑ 3.0 3.1 3.2 3.3 "Skytrofa EPAR". 10 November 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/lonapegsomatropin-ascendis-pharma.
- ↑ "Skytrofa Product information". https://ec.europa.eu/health/documents/community-register/html/h1607.htm.
- ↑ "Ascendis Pharma A/S Announces U.S. Food and Drug Administration Approval of Skytrofa (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency". Ascendis Pharma (Press release). 25 August 2021. Retrieved 25 August 2021.
- ↑ (PDF) Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (Report). 13 May 2022. https://www.fda.gov/media/155227/download. Retrieved 22 January 2023.
This article incorporates text from this source, which is in the public domain.
Further reading
- "Weekly Lonapegsomatropin in Treatment-Naïve Children with Growth Hormone Deficiency: The Phase 3 heiGHt Trial". The Journal of Clinical Endocrinology and Metabolism 106 (11): 3184–3195. July 2021. doi:10.1210/clinem/dgab529. PMID 34272849.
External links
- "Lonapegsomatropin". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/lonapegsomatropin.
- Clinical trial number NCT02781727 for "A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)" at ClinicalTrials.gov
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