Somapacitan, sold under the brand name Sogroya, is a

growth hormone Growth hormone (GH) or somatotropin, also known as human growth hormone (hGH or HGH) in its human form, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is thus important in h ...

medication. Somapacitan is a human growth hormone analog. Somapacitan-beco is produced in ''

Escherichia coli ''Escherichia coli'' (),Wells, J. C. (2000) Longman Pronunciation Dictionary. Harlow ngland Pearson Education Ltd. also known as ''E. coli'' (), is a Gram-negative, facultative anaerobic, rod-shaped, coliform bacterium of the genus '' Esc ...

'' by

recombinant DNA technology Molecular cloning is a set of experimental methods in molecular biology that are used to assemble recombinant DNA molecules and to direct their replication within host organisms. The use of the word ''cloning'' refers to the fact that the metho ...

. 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. It was approved for medical use in the United States in August 2020, and in the European Union in March 2021. Somapacitan is the first human growth hormone (hGH) therapy that adults only take once a week by injection under the skin; other

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

-approved hGH formulations for adults with growth hormone deficiency must be administered daily. It contains a small non-covalent moiety that reversibly binds to serum albumin which slows down elimination.

Medical uses

Somapacitan is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). GHD is a condition when the body doesn't produce enough growth hormone on its own. 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.

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.

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

Society and culture

Legal status

Somapacitan was approved for medical use in the United States in August 2020. The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) granted the approval of Sogroya to Novo Nordisk, Inc. On 28 January 2021, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regardin ...

(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. The applicant for this medicinal product is Novo Nordisk A/S. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Somapacitan was approved for medical use in the European Union in March 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

References

External links

* * {{Portal bar , Medicine Growth hormones Orphan drugs