Chemistry:Somatrogon
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| Trade names | Ngenla |
| Other names | MOD-4023, somatrogon-ghla |
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| Routes of administration | Subcutaneous injection |
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Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency.[1][4][6] Somatrogon is a glycosylated protein constructed from human growth hormone and a small part of human chorionic gonadotropin which is appended to both the N-terminal and C-terminal.[6]
The most common side effects include reactions at the site of injection, headache, and fever.[5]
Somatrogon was approved for medical use in Australia in November 2021,[1] in the European Union in February 2022,[5] and in the United States in June 2023.[7]
Society and culture
Legal status
On 16 December 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ngenla, intended for the treatment of growth hormone deficiency in children and adolescents from three years of age.[8] The applicant for this medicinal product is Pfizer Europe MA EEIG.[8] Somatrogon was approved for medical use in the European Union in February 2022.[5][9]
Names
Somatrogon is the international nonproprietary name.[10]
References
- ↑ 1.0 1.1 1.2 1.3 "Ngenla". 13 December 2021. https://www.tga.gov.au/apm-summary/ngenla.
- ↑ "Updates to the Prescribing Medicines in Pregnancy database". 21 December 2022. https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database.
- ↑ "Summary Basis of Decision (SBD) for Ngenla". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00572&lang=en.
- ↑ 4.0 4.1 "Ngenla- somatrogon-ghla injection, solution". 26 July 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06dce529-b741-4a1b-8842-3ad77be6e308.
- ↑ 5.0 5.1 5.2 5.3 "Ngenla EPAR". 14 December 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/ngenla. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 6.0 6.1 "Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency" (Press release). Opko Health. 24 September 2021. Retrieved 18 December 2021 – via GlobeNewswire.
- ↑ "FDA Approves Pfizer's Ngenla, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency". Pfizer. 2023-06-28. https://www.businesswire.com/news/home/20230627678641/en/FDA-Approves-Pfizer%E2%80%99s-NGENLA%E2%84%A2-a-Long-Acting-Once-Weekly-Treatment-for-Pediatric-Growth-Hormone-Deficiency.
- ↑ 8.0 8.1 "Ngenla: Pending EC decision". 16 December 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ngenla. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Ngenla Product information". https://ec.europa.eu/health/documents/community-register/html/h1617.htm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information 31 (1). 2017.
Further reading
- "Pharmacokinetic and Pharmacodynamic Modeling of MOD-4023, a Long-Acting Human Growth Hormone, in Growth Hormone Deficiency Children". Hormone Research in Paediatrics 87 (5): 324–332. 2017. doi:10.1159/000470842. PMID 28399519.
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