Somatrogon Explained

Tradename:Ngenla
Dailymedid:Somatrogon
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:Subcutaneous
Atc Prefix:H01
Atc Suffix:AC08
Legal Au:S4
Legal Au Comment:[2]
Legal Br:C5
Legal Br Comment:[3]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[4] [5]
Legal Us:Rx-only
Legal Us Comment:[6]
Legal Eu:Rx-only
Cas Number:1663481-09-1
Drugbank:DB14960
Unii:6D848RA61B
Kegg:D10990
Synonyms:MOD-4023, somatrogon-ghla

Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency.[7] 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.[7] Somatrogon is a human growth hormone analog.

The most common side effects include reactions at the site of injection, headache, and fever.

Somatrogon was approved for medical use in Australia in November 2021, in the European Union in February 2022, and in the United States in June 2023.[8] [9]

Medical uses

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

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

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. The applicant for this medicinal product is Pfizer Europe MA EEIG.[10] Somatrogon was approved for medical use in the European Union in February 2022.[11] [12]

Names

Somatrogon is the international nonproprietary name.[13]

Further reading

Notes and References

  1. Web site: Updates to the Prescribing Medicines in Pregnancy database . Therapeutic Goods Administration (TGA) . 21 December 2022 . 2 January 2023.
  2. Web site: Ngenla . Therapeutic Goods Administration (TGA) . 13 December 2021 . 28 December 2021.
  3. Web site: Anvisa . Brazilian Health Regulatory Agency . 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. live . https://web.archive.org/web/20231019120956/https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-816-de-15-de-setembro-de-2023-510390164 . 2023-10-19 . 2023-10-19 . . pt-BR . 2023-09-18.
  4. Web site: Summary Basis of Decision (SBD) for Ngenla . Health Canada . 23 October 2014 . 29 May 2022.
  5. Web site: Health product highlights 2021: Annexes of products approved in 2021 . . 3 August 2022 . 25 March 2024.
  6. Web site: Ngenla- somatrogon-ghla injection, solution . DailyMed . 26 July 2023 . 29 August 2023.
  7. Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency . Opko Health . GlobeNewswire . 24 September 2021 . 18 December 2021.
  8. Web site: Drug Trials Snapshots: Ngenla . U.S. Food and Drug Administration (FDA) . 27 June 2023 . 3 April 2024.
  9. FDA Approves Pfizer's Ngenla, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency . Pfizer . Business Wire . 2023-06-28 . 2023-07-03.
  10. Web site: Ngenla: Pending EC decision . European Medicines Agency (EMA) . 16 December 2021 . 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. Web site: Ngenla EPAR . European Medicines Agency . 14 December 2021 . 2 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. Web site: Ngenla Product information . Union Register of medicinal products . 3 March 2023.
  13. ((World Health Organization)) . 2017 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77 . WHO Drug Information . 31 . 1 . 10665/330984 . free . World Health Organization .

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