| Clinical data | |
|---|---|
| Trade names | Ngenla |
| Other names | MOD-4023, somatrogon-ghla |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623041 |
| License data |
|
| Pregnancy category | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency.[1][6][8] 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.[8] Somatrogon is a human growth hormone analog.[6]
The most common side effects include reactions at the site of injection, headache, and fever.[7]
Somatrogon was approved for medical use in Australia in November 2021,[1] in the European Union in February 2022,[7] and in the United States in June 2023.[6][9][10]
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Transcription
Medical uses
Somatrogon is indicated for the treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.[6][9]
History
The US Food and Drug Administration (FDA) approved somatrogon based on one clinical trial (NCT02968004) of 224 children with growth hormone deficiency and short stature.[9] The trial was conducted at 84 sites in 24 countries including Argentina, Australia, Bulgaria, Belarus, Canada, Colombia, Germany, Georgia, Greece, India, Israel, Italy, Mexico, New Zealand, Poland, South Korea, Russia, Spain, Taiwan, Turkey, Ukraine, the United Kingdom, Vietnam, and the United States.[9] This trial was used to assess efficacy and safety.[9] The benefits and side effects were evaluated in a clinical trial.[9] Children aged 3 to 12 years old were assigned at random to weekly somatrogon or another daily approved growth hormone for 52 weeks.[9]
Society and culture
Legal status
In 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.[11] The applicant for this medicinal product is Pfizer Europe MA EEIG.[11] Somatrogon was approved for medical use in the European Union in February 2022.[7][12]
Names
Somatrogon is the international nonproprietary name.[13]
References
- ^ a b c d "Ngenla". Therapeutic Goods Administration (TGA). 13 December 2021. Retrieved 28 December 2021.
- ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Retrieved 2 January 2023.
- ^ Anvisa (15 September 2023). "RDC Nº 816 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 816 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 18 September 2023). Archived from the original on 19 October 2023. Retrieved 19 October 2023.
- ^ "Summary Basis of Decision (SBD) for Ngenla". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
- ^ a b c d e "Ngenla- somatrogon-ghla injection, solution". DailyMed. 26 July 2023. Retrieved 29 August 2023.
- ^ a b c d "Ngenla EPAR". European Medicines Agency. 14 December 2021. Retrieved 2 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "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.
- ^ a b c d e f g "Drug Trials Snapshots: Ngenla". U.S. Food and Drug Administration (FDA). 27 June 2023. Retrieved 3 April 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "FDA Approves Pfizer's Ngenla, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency" (Press release). Pfizer. 28 June 2023. Retrieved 3 July 2023 – via Business Wire.
- ^ a b "Ngenla: Pending EC decision". European Medicines Agency (EMA). 16 December 2021. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Ngenla Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
Further reading
- Fisher DM, Rosenfeld RG, Jaron-Mendelson M, Amitzi L, Koren R, Hart G (2017). "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. doi:10.1159/000470842. PMC 5637306. PMID 28399519.
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This page was last edited on 14 April 2024, at 07:30