2. • Somapacitan is a growth hormone medication.
• It is the human growth hormone analogue.
• Somapacitan is produced in Escherichia coli by the method of recombinant DNA
technology.
• Growth hormone (GH) deficiency (GHD) is a disorder that occurs when the pituitary
gland does not secrete sufficient amounts of GH.
• In children, GHD is manifested by short stature relative to the reference population and
a low growth velocity.
• Adult GHD is associated with abnormalities in metabolism and body composition, and
with an increased risk of cardiovascular disease.
• The current therapy for GHD involves daily subcutaneous (s.c.) injections with GH
replacement that is associated with a treatment burden, which may impact adherence.
• Somapacitan, a long-acting GH derivative, is approved for once-weekly treatment of
GHD in adults and currently in clinical development for once-weekly administration in
children.
3. UNIQUENESS OF THE DRUG-
• The half-life of Somapacitan is prolonged with a well-established protraction method,
which is also used in insulin and glucagon-like peptide-1 therapies.
• Somapacitan is a novel once-weekly reversible albumin-binding GH derivative, with a
small albumin-binding moiety attached to the GH molecule.
• This facilitates reversible binding to circulating endogenous albumin, thereby reducing
the clearance and extending the half-life of Somapacitan, allowing once-weekly
administration.
Mechanism of action
• Somapacitan binds to the growth hormone receptor and induces intracellular signaling
to up-regulate insulin-like growth factor I (IGF-1).
• IGF-1 causes growth in bones and muscle tissue.
• Growth hormones more directly cause the fusion of myoblasts and myotubes to cause
muscle fiber growth, activate neural stem cells, and induce chondrocyte proliferation.
4. • Somapacitan is a long-acting recombinant human GH derivative with a single
substitution in the peptide backbone (leucine [L] at position 101 substituted with
cysteine [C]) to which an albumin binding moiety has been attached.
• The albumin binding moiety (side-chain) consists of a C16 fatty acid moiety and a
hydrophilic spacer attached to position 101 of the protein by chemical conjugation.
• The non-covalent, reversible binding to endogenous albumin delays the elimination of
Somapacitan and thereby prolongs the in vivo half-life (t½ and duration of action).
5. • The pharmacological effects of Somapacitan are like those of human GH. These include
stimulation of somatic growth, especially skeletal and muscle growth and maintenance.
• In addition, human GH has many other effects on the body including increasing
lipolysis, protein synthesis, muscle mass, and gluconeogenesis in the liver, and reducing
glucose uptake in the liver.
• As for human GH, the mechanism of action
of Somapacitan is either direct via the GH
receptor or indirect via stimulation of IGF-I
expression and release.
6. • Volume of distribution
The approximate volume of distribution of somapacitan is 14.6 L.
• Protein binding
Somapacitan is >99% bound to albumin.
• Metabolism
Studies in humans and rats show that somapacitan is metabolized through
cleavage of the albumin-binding moiety and linker sidechain before further non-
specific mechanisms.
• Route of elimination
Somapacitan is approximately 81% eliminated in the urine and 13% in the feces.
7. • Half-life
The elimination half life of Somapacitan is 2-3 days.
• Clearance
The apparent maximum rate of saturable elimination is estimated to be 0.268 ± 0.03
mg/h.
• Toxicity-
Patients experiencing an acute overdose of Somapacitan may present with fluid
retention.6 Chronic overdose may resemble gigantism or acromegaly
• International/Other Brands-
Sogroya (Novo Nordisk)
8. Adventitious agents
• As no raw materials of human or animal origin are used for the manufacture of
Somapacitan, the finished product is evaluated to be safe with regards to TSE agents.
• The producing host strain is E. coli, and since it is not the natural host for mammalian
viruses, no testing for endogenous or adventitious viruses has been performed.
• A recombinant enzyme is a raw material used during the manufacturing process of
Somapacitan active substance. This enzyme is expressed in a cell line and produced
using a serum-free cell cultivation process.
• Furthermore, only non-animal derived raw materials are used during the production of
the raw material. The risk of TSE is therefore negligible, and the risk of a contamination
with adventitious agents is also minimized.
9. Side effects of Sogroya include:
• back pain
• joint pain
• indigestion/heartburn
• sleep disorder
• dizziness
• tonsillitis
• vomiting
• adrenal insufficiency
• high blood pressure (hypertension)
• increased blood creatine phosphokinase
• weight gain
• anemia
10. Sogroya In Children
• The safety and effectiveness of Sogroya have not been established in pediatric patients.
• Risks in pediatric patients associated with growth hormone use include:
• Sudden death in pediatric patients with Prader-Willi Syndrome
• Increased risk of second neoplasm in pediatric cancer survivors treated with radiation
to the brain and/or head
• Slipped capital femoral epiphysis
• Progression of preexisting scoliosis
• Pancreatitis
11. What Drugs, Substances, or Supplements Interact with Sogroya?
Sogroya may interact with other medicines such as:
• glucocorticoids,
• cytochrome P450-metabolized drugs,
• oral estrogen, and
• insulin and/or other hypoglycemic agents
Sogroya During Pregnancy and Breastfeeding
• There are no available data on Sogroya use in pregnant women; however, published
studies with short-acting recombinant growth hormone (rhGH) use in pregnant women
over several decades have not identified any drug-associated risk of major birth
defects, miscarriage, or adverse maternal or fetal outcomes.
• It is unknown if Sogroya passes into breast milk.
12.
13. Legal status-
• Somapacitan was approved for medical use in the United States in August 2020. The
U.S. Food and Drug Administration (FDA) granted the approval of Sogroya to Novo
Nordisk, Inc.
Other names-
Somapacitan-beco, NNC0195-0092
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.
