Somatrogon

Somatrogon
Clinical data
Trade names	Ngenla
Other names	MOD-4023
Pregnancy; category	AU: B1; ;
Routes of; administration	Subcutaneous injection
ATC code	H01AC08 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only) ; EU: Rx-only ;
Identifiers
CAS Number	1663481-09-1;
DrugBank	DB14960;
UNII	6D848RA61B;
KEGG	D10990;

Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency.^[1]^[3] 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.^[3]

The most common side effects include reactions at the site of injection, headache, and fever.^[2]

Somatrogon was approved for medical use in Australia in November 2021,^[1] and in the European Union in February 2022.^[2]

Society and culture[]

Legal status[]

On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ngenla, intended for the treatment of growth hormone deficiency (GHD) in children and adolescents from three years of age.^[4] The applicant for this medicinal product is Pfizer Europe MA EEIG.^[4] Somatrogon was approved for medical use in the European Union in February 2022.^[2]

Names[]

Somatrogon is the international nonproprietary name (INN).^[5]

References[]

^ ^a ^b ^c ^d "Ngenla". Therapeutic Goods Administration (TGA). 13 December 2021. Retrieved 28 December 2021.
^ ^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 "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.
^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

External links[]

"Somatrogon". Drug Information Portal. U.S. National Library of Medicine.

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[Ngenla_APM_Summary-1] "Ngenla". Therapeutic Goods Administration (TGA). 13 December 2021. Retrieved 28 December 2021.

[Ngenla_EPAR-2] "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.

[poa-3] "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.

[Ngenla:_Pending_EC_decision-4] "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.

[5] World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

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