Somatrogon

Somatrogon
Names
Trade namesNgenla
Other namesMOD-4023, somatrogon-ghla
Clinical data
Pregnancy
category
Routes of
use		Subcutaneous
External links
AHFS/Drugs.comMonograph
MedlinePlusa623041
Legal
License data
Legal status

Somatrogon, sold under the brand name Ngenla, is a medication used to treat growth hormone deficiency in children.[7][6] It may be started at 3 years old.[6] It is given by injection under the skin once per week.[6] Once growth plates are closed, it is no longer useful.[6]

Common side effects include reactions at the injection site, headache, and fever.[6] Other side effects may include diabetes, swelling, low thyroid, and slipped capital femoral epiphysis.[7] It should not be used by those who are seriously ill or who have active cancer.[7] It is a version of human growth hormone.[6] It is a recombinant protein made by attaching human growth hormone to a part of human chorionic gonadotropin.[6]

Somatrogon was approved for medical use in Australia in 2021,[1] Europe in 2022,[6] and the United States in 2023.[7] In Canada it costs about 10,000 CAD per year for a 20 kg person.[8] This amount in the United States is about 54,000 USD as of 2024.[9]

Medical uses

Somatrogon is indicated for the treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.[7][10]

It works aswell as somatropin but only needs to be given once per week.[6]

Dosage

The dose is generally 0.66 mg/kg once per week.[6]

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.[10] 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.[10] This trial was used to assess efficacy and safety.[10] The benefits and side effects were evaluated in a clinical trial.[10] Children aged 3 to 12 years old were assigned at random to weekly somatrogon or another daily approved growth hormone for 52 weeks.[10]

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.[6][12]

Names

Somatrogon is the international nonproprietary name.[13]

References

  1. ↑ 1.0 1.1 1.2 "Ngenla". Therapeutic Goods Administration (TGA). 13 December 2021. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
  2. ↑ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  3. ↑ Anvisa (2023-09-15). "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 português do Brasil). Diário Oficial da União (published 2023-09-18). Archived from the original on 2023-10-19. Retrieved 2023-10-19.
  4. ↑ "Summary Basis of Decision (SBD) for Ngenla". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  5. ↑ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
  6. ↑ 6.00 6.01 6.02 6.03 6.04 6.05 6.06 6.07 6.08 6.09 6.10 6.11 "Ngenla EPAR". European Medicines Agency. 14 December 2021. Archived from the original on 3 March 2022. Retrieved 2 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ↑ 7.0 7.1 7.2 7.3 7.4 7.5 "Ngenla- somatrogon-ghla injection, solution". DailyMed. 26 July 2023. Archived from the original on 29 August 2023. Retrieved 29 August 2023.
  8. ↑ "Table 4, Summary of Economic Evaluation". www.ncbi.nlm.nih.gov. March 2022. Archived from the original on 9 July 2024. Retrieved 7 July 2024.
  9. ↑ "Ngenla Prices, Coupons, Copay Cards & Patient Assistance". Drugs.com. Archived from the original on 19 June 2024. Retrieved 7 July 2024.
  10. ↑ 10.0 10.1 10.2 10.3 10.4 10.5 "Drug Trials Snapshots: Ngenla". U.S. Food and Drug Administration (FDA). 27 June 2023. Archived from the original on 3 April 2024. Retrieved 3 April 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ↑ 11.0 11.1 "Ngenla: Pending EC decision". European Medicines Agency (EMA). 16 December 2021. Archived from the original on 17 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.
  12. ↑ "Ngenla Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  13. ↑ 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

External links

Identifiers:


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