Somatrogon

Somatrogon
Clinical data
Trade namesNgenla
Other namesMOD-4023
Pregnancy
category
Routes of
administration		Subcutaneous injection
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [1]
Identifiers
CAS Number
DrugBank
UNII
KEGG

Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency.[1][2] 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.[2]

Society and culture

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 3 years of age.[3] The applicant for this medicinal product is Pfizer Europe MA EEIG.[3]

Somatrogon was approved for medical use in Australia in November 2021.[1]

References

  1. 1 2 3 4 "Ngenla". Therapeutic Goods Administration (TGA). 13 December 2021. Retrieved 28 December 2021.
  2. 1 2 "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.
  3. 1 2 "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.

Further reading

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


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