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Somapacitan

Somapacitan
Clinical data
Trade namesSogroya
Other namesNNC0195-0092, somapacitan-beco
AHFS/Drugs.comMonograph
MedlinePlusa622020
License data
Pregnancy
category
Routes of
administration		Subcutaneous[3][4]
Drug classHuman growth hormone analog
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC1038H1609N273O319S9
Molar mass23305.42 g·mol−1

Somapacitan, sold under the brand name Sogroya, is a growth hormone medication.[3][10] Somapacitan is a human growth hormone analog.[3] Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.[3]

The most common side effects include: back pain, joint paint, indigestion, a sleep disorder, dizziness, tonsillitis, swelling in the arms or lower legs, vomiting, adrenal insufficiency, hypertension, increase in blood creatine phosphokinase (a type of enzyme), weight increase, and anemia.[10][4]

It was approved for medical use in the United States in August 2020,[10][13][14][4] and in the European Union in March 2021.[11]

Somapacitan is the first human growth hormone (hGH) therapy that adults only take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily.[10] It contains a small non-covalent moiety that reversibly binds to serum albumin which slows down elimination.[15]

Medical uses

Somapacitan is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).[3][10][4]

GHD is a condition when the body doesn't produce enough growth hormone on its own.[4] Growth hormone regulates many functions in the body including accumulation of fat in the trunk or central area of the body that can be associated with serious medical issues.[4]

Contraindications

Somapacitan should not be used in people with active malignancy, any stage of diabetic eye disease in which high blood sugar levels cause damage to blood vessels in the retina, acute critical illness, or those with acute respiratory failure, because of the increased risk of mortality with use of pharmacologic doses of somapacitan in critically ill individuals without growth hormone deficiency.[10]

History

Somapacitan was evaluated in a randomized, double-blind, placebo-controlled trial (NCT02229851) in 300 participants with growth hormone deficiency who had never received growth hormone treatment or had stopped treatment with other growth hormone formulations at least three months before the study.[10][4] Participants were randomly assigned to receive injections of weekly somapacitan, weekly placebo (inactive treatment), or daily somatropin, an FDA-approved growth hormone.[10] The effectiveness of somapacitan was determined by the percentage change of truncal fat, the fat that is accumulated in the trunk or central area of the body that is regulated by growth hormone and can be associated with serious medical issues.[10] The trial was conducted at 92 sites in 16 countries: the United States, Australia, Germany, India, Japan, Latvia, Lithuania, Malaysia, Poland, Romania, Russian Fed, South Africa, Sweden, Turkey, Ukraine and the United Kingdom.[4]

Adult participants were assigned at random to weekly Sogroya or placebo injections for 34 weeks.[4] Neither the participants nor the investigators knew which treatment was given until the end of the trial.[4] One additional group of participants with GHD received daily injections of somatotropin (an approved treatment for GHD).[4] At the end of the 34-week treatment period, truncal fat decreased by 1.06%, on average, among participants taking weekly somapacitan while it increased among participants taking the placebo by 0.47%.[10] In the daily somatropin group, truncal fat decreased by 2.23%.[10] Participants in the weekly somapacitan and daily somatropin groups had similar improvements in other clinical endpoints.[10]

Society and culture

Somapacitan was approved for medical use in the United States in August 2020.[10][14][4] The U.S. Food and Drug Administration (FDA) granted the approval of Sogroya to Novo Nordisk, Inc.[10][14]

In January 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 Sogroya, intended for the treatment of growth hormone deficiency in adults.[11] The applicant for this medicinal product is Novo Nordisk A/S.[11] Somapacitan was approved for medical use in the European Union in March 2021.[11]

References

  1. ^ a b "Sogroya APMDS". Therapeutic Goods Administration (TGA). 7 March 2022. Retrieved 23 March 2022.
  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. ^ a b c d e f "Sogroya- somapacitan-beco injection, solution". DailyMed. 1 October 2021. Archived from the original on 23 April 2022. Retrieved 23 April 2022.
  4. ^ a b c d e f g h i j k l "Drug Trial Snapshot: Sogroya". U.S. Food and Drug Administration (FDA). 28 August 2020. Archived from the original on 21 September 2020. Retrieved 16 September 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ "Sogroya". Therapeutic Goods Administration (TGA). Retrieved 23 March 2022.[permanent dead link‍]
  6. ^ 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.
  7. ^ "Details for: Sogroya". Health Canada. 27 November 2023. Retrieved 3 March 2024.
  8. ^ "Summary Basis of Decision (SBD) for Sogroya". Health Canada. 1 September 2012. Retrieved 11 December 2023.
  9. ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada. 26 October 2023. Retrieved 3 January 2024.
  10. ^ a b c d e f g h i j k l m n o "FDA approves weekly therapy for adult growth hormone deficiency". U.S. Food and Drug Administration (FDA) (Press release). 1 September 2020. Archived from the original on 1 September 2020. Retrieved 1 September 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ a b c d e "Sogroya EPAR". European Medicines Agency. 25 January 2021. Archived from the original on 23 April 2022. Retrieved 23 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. ^ "Sogroya Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  13. ^ "FDA approves once-weekly Sogroya for the treatment of adult growth hormone deficiency". Novo Nordisk (Press release). 28 August 2020. Archived from the original on 1 September 2020. Retrieved 1 September 2020.
  14. ^ a b c "Sogroya: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 29 October 2020. Retrieved 2 September 2020.
  15. ^ Yuen KC, Miller BS, Boguszewski CL, Hoffman AR (February 2022). Mancini A, Persani L, Arosio M, Kreitschmann-Andermahr I (eds.). "Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs". Front Endocrinol. 12. Frontiers Media SA: 32. doi:10.3389/fendo.2021.637209. ISBN 978-2-88974-443-5. PMC 7943875. PMID 33716988. Archived from the original on 30 September 2022. Retrieved 24 April 2022.
  • Clinical trial number NCT02229851 for "Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin FlexPro (Somatropin) in Adults With Growth Hormone Deficiency. (REAL 1)" at ClinicalTrials.gov
Quelle: https://en.wikipedia.org/wiki/Somapacitan-beco