Somapacitan

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Somapacitan
Names
Trade namesSogroya
Other namesSomapacitan-beco, NNC0195-0092
Clinical data
Drug classHuman growth hormone analog
Main usesGrowth hormone deficiency[1]
Side effectsBack pain, joint paint, indigestion, sleep problems, dizziness, tonsillitis, swelling of the arms or legs, vomiting, adrenal insufficiency, high blood pressure, weight gain, low red blood cells[1]
Pregnancy
category
Routes of
use		Subcutaneous[1][3]
External links
AHFS/Drugs.comProfessional Drug Facts
Legal
License data
Legal status
Chemical and physical data
FormulaC1038H1609N273O319S9
Molar mass23305.42 g·mol−1

Somapacitan, sold under the brand name Sogroya, is a medication used to treat growth hormone deficiency in adults.[1] It is given by injection under the skin.[1]

Common side effects include back pain, joint paint, indigestion, sleep problems, dizziness, tonsillitis, swelling of the arms or legs, vomiting, adrenal insufficiency, high blood pressure, weight gain, and low red blood cells.[1] Other side effects may include cancer, diabetes, intracranial hypertension, allergic reactions, hypoadrenalism, and pancreatitis.[1] Use appears to be safe in pregnancy.[1] It is a human growth hormone analog.[1]

Somapacitan was approved for medical use in the United States in 2020 and Europe and the United Kingdom in 2021.[1][4][7] It is produced in Escherichia coli by recombinant DNA technology.[1]

Medical uses

Somapacitan is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).[1][6][3]

Benefits appear similar to somatropin.[4]

Dosage

It is started at a dose of 1.5 mg.[1] It is given once per week.[1] Doses may be increased up to 8 mg based on response and insulin-like growth factor 1 levels.[1]

Side effects

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.[6]

Mechanism of action

GHD is a condition when the body doesn't produce enough growth hormone on its own.[3] 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.[3]

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.[6][3] Participants were randomly assigned to receive injections of weekly somapacitan, weekly placebo (inactive treatment), or daily somatropin, an FDA-approved growth hormone.[6] 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.[6] 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.[3]

Adult participants were assigned at random to weekly Sogroya or placebo injections for 34 weeks.[3] Neither the participants nor the investigators knew which treatment was given until the end of the trial.[3] One additional group of participants with GHD received daily injections of somatotropin (an approved treatment for GHD).[3] 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%.[6] In the daily somatropin group, truncal fat decreased by 2.23%.[6] Participants in the weekly somapacitan and daily somatropin groups had similar improvements in other clinical endpoints.[6]

Somapacitan is the first human growth hormone (hGH) therapy that adults take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily.[6] It contains a small non-covalent moiety that reversibly binds to serum albumin which slows down elimination.[8]

Society and culture

Legal status

Somapacitan was approved for medical use in the United States in August 2020.[6][9][3] The U.S. Food and Drug Administration (FDA) granted the approval of Sogroya to Novo Nordisk, Inc.[6][9]

On 28 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.[10] The applicant for this medicinal product is Novo Nordisk A/S.[10] Somapacitan was approved for medical use in the European Union in March 2021.[4]

See also

References

  1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 1.14 1.15 "Sogroya- somapacitan-beco injection, solution". DailyMed. 1 October 2021. Archived from the original on 23 April 2022. Retrieved 23 April 2022.
  2. ↑ 2.0 2.1 "Sogroya APMDS". Therapeutic Goods Administration (TGA). 7 March 2022. Retrieved 23 March 2022.{{cite web}}: CS1 maint: url-status (link)
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 "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.
  4. ↑ 4.0 4.1 4.2 4.3 "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 © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ↑ "Sogroya". Therapeutic Goods Administration (TGA). Retrieved 23 March 2022.{{cite web}}: CS1 maint: url-status (link)
  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 "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.
  7. ↑ "Somapacitan". SPS - Specialist Pharmacy Service. 24 March 2017. Archived from the original on 3 March 2022. Retrieved 3 November 2022.
  8. ↑ 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. Frontiers Media SA. 12: 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.
  9. ↑ 9.0 9.1 "Sogroya: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 29 October 2020. Retrieved 2 September 2020.
  10. ↑ 10.0 10.1 "Sogroya: Pending EC decision". European Medicines Agency (EMA). 29 January 2021. Archived from the original on 1 February 2021. Retrieved 1 February 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links

External sites:
Identifiers:
  • 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
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