PLAINSBORO, NJ, April 28, 2023 – Novo Nordisk
announced today that the U.S. Food and Drug Administration (FDA) has
approved a new indication for Sogroya® (somapacitan-beco)
injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5
years and older who have growth failure due to inadequate secretion of
endogenous growth hormone.1 With this new indication,
Sogroya® becomes the first and only once-weekly growth
hormone (GH) treatment for both children and adults.1
The FDA approval of the new indication for children with GHD is
based on data from the phase 3 REAL4 study. In the study, two hundred
treatment-naïve patients aged 2.5 – 11 years with GHD were either
given once-weekly Sogroya® (n=132) or daily somatropin
(n=68) for 52 weeks.1 The results showed that
Sogroya® was comparable to daily somatropin for the primary
endpoint of annualized height velocity (11.2 cm/year vs. 11.7 cm/year,
respectively).2 Adverse reactions in the REAL4 study
occurring in more than 5% of patients included nasopharyngitis,
headache, pyrexia, pain in extremity, and injection site reactions.1
Children with GHD typically experience short stature and can also
have an increased risk for other growth-associated
problems.3 For decades, GH replacement has been the
standard of care to improve growth outcomes.4,5 Patients
may struggle with a daily injection routine over the long term, and
according to the Growth Hormone Research Society consensus, a
once-weekly GH option offers patients and families a therapeutic alternative.6,7
“At Novo Nordisk, we continue to build on our 25-year heritage and
expertise in rare endocrine disorders, including growth hormone
deficiency, to deliver a broad range of products and services to the
community. A once-weekly growth hormone treatment like
Sogroya® may offer a therapeutic alternative for patients
and their caregivers interested in a once-weekly option,” said
Stephanie Seremetis, MD, CMO and CVP, Rare Disease, Novo Nordisk.
Sogroya® leverages albumin-binding technology developed
by Novo Nordisk for other disease areas.1,8 It binds to
endogenous albumin, which delays elimination of somapacitan-beco and
thereby prolongs the in vivo half-life and duration of action.1
The Sogroya® pen is based on the FlexPro®
pen, which has more than 10 years of patient experience.9
Sogroya® will be provided in a prefilled, premixed,
portable pen that is stable at room temperature (up to
77oF) for up to a maximum of 72 hours.1
Novo Nordisk plans to make Sogroya® available for both
pediatric and adult patients in the coming months.
What is
Sogroya®
?
- Sogroya® (somapacitan-beco) injection 5 mg, 10 mg
or 15 mg is a prescription medicine that contains human growth
hormone, the same growth hormone made by the body.
- It is
given by injection under the skin (subcutaneous) and is used to
treat adults and children 2.5 years and older who do not make enough
growth hormone.
Important Safety Information
Do not use Sogroya® if:
- you have a critical illness caused by certain types of heart
or stomach surgery, trauma or breathing problems
- you have
cancer or other tumors
- you are allergic to
somapacitan-beco or any of the ingredients in Sogroya
®
- your healthcare provider tells you
that you have certain types of eye problems caused by diabetes
- you are a child with closed bone growth plates
- you are
a child with Prader-Willi syndrome who is severely obese or has
breathing problems including sleep apnea (briefly stopping breathing
during sleep)
Before taking Sogroya®, tell your healthcare
provider about all of your medical conditions, including if you:
- have had heart or stomach surgery, trauma,
or serious breathing problems
|
- are taking replacement therapy with
glucocorticoids
|
- have had cancer or any tumor
| - have thyroid gland problems
|
| | |
- have adrenal gland problems
| - are a child with a history of
worsening of curvature of the spine (scoliosis)
|
- are pregnant or plan to become pregnant. It is not known if Sogroya
® will harm your unborn baby. Talk to your
healthcare provider if you are pregnant or plan to become
pregnant
- are breastfeeding or plan to breastfeed. It is not
known if Sogroya
® passes into your breast milk. You and your
healthcare provider should decide if you will take Sogroya
® while you breastfeed
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Sogroya® may affect the
way some medicines work, and some medicines may affect how
Sogroya® works.
How should I use
Sogroya®
?
- Use Sogroya
® exactly as your healthcare provider tells
you to
- Use Sogroya®
1 time each week
- If you miss a dose of
Sogroya®, the missed dose can be taken within 3 days (72
hours) after the scheduled dosing day. One-time weekly dosing for
the next dose can be started again on the regularly scheduled dosing
day
- If more than 3 days (72 hours) have passed, skip the
missed dose, and take your next dose on the regularly scheduled
dosing day
- Sogroya® pens are for use by 1
person only
-
Do not share your Sogroya® pens and needles with
another person, even if the needle has been changed. You may give
another person an infection or get an infection from
them
What are the possible side effects of
Sogroya®
?
Sogroya®
may cause serious side effects, including:
- high risk of death in people who have critical illnesses
because of heart or stomach surgery, trauma, or serious breathing
problems
- increased risk of growth of cancer or a tumor that
is already present and increased risk of the return of cancer or a
tumor in people who were treated with radiation to the brain or head
as children and who developed low growth hormone problems. You or
your child’s healthcare provider will need to monitor you or your
child for a return of cancer or a tumor. Contact the healthcare
provider if you or your child start to have sudden changes in
behavior, headaches, vision problems, or changes in moles,
birthmarks, or the color of your or your child’s skin
- new
or worsening high blood sugar or diabetes. You or your child’s blood
sugar may need to be monitored during treatment with
Sogroya®
- increase in pressure in the skull. If
you or your child have headaches, eye problems, nausea or vomiting,
contact the healthcare provider
- serious allergic
reactions. Get medical help right away if you or your child have the
following symptoms: swelling of your face, lips, mouth, or tongue,
trouble breathing, wheezing, severe itching, skin rashes, redness,
or swelling, dizziness or fainting, fast heartbeat or pounding in
your chest, sweating
- your or your child’s body holding too
much fluid (fluid retention) such as swelling in the hands and feet,
pain in your or your child’s joints or muscles or nerve problems
that cause pain, burning or tingling in the hands, arms, legs, and
feet. Tell your or your child’s healthcare provider if you or your
child have any of these signs or symptoms of fluid retention
- decrease in a hormone called cortisol. The healthcare provider
will do blood tests to check your or your child’s cortisol levels.
Tell your or your child’s healthcare provider if you or your child
have darkening of the skin, severe fatigue, dizziness, weakness, or
weight loss
- decrease in thyroid hormone levels. Decreased
thyroid hormone levels may affect how well Sogroya
® works. The healthcare provider will do blood
tests to check you or your child’s thyroid hormone levels
- severe and constant abdominal pain. This could be a sign of
pancreatitis. Tell your or your child’s healthcare provider if you
or your child has any new abdominal pain
- loss of fat and
tissue weakness in the area of skin you or your child inject. Talk
to your or your child’s healthcare provider about rotating the areas
where you or your child inject Sogroya®
- worsening of curvature of the spine in children (scoliosis)
- hip and knee pain or a limp in children (slipped capital femoral
epiphysis)
- high risk of sudden death in children with
Prader-Willi syndrome who are severely obese or have breathing
problems, including sleep apnea
- increase in phosphorus,
alkaline phosphatase, and parathyroid hormone levels in your blood.
You or your child’s healthcare provider will do blood tests to check
this
The most common side effects of Sogroya® in
children include: common cold, headache, fever, pain in
extremity, and reaction to injection
The most common side effects of Sogroya® in adults
include: back pain, joint pain, indigestion, sleep
problems, dizziness, swelling of the tonsils (tonsillitis), vomiting,
high blood pressure, increase in the level of an enzyme in your blood
called creatine phosphokinase, weight gain, and low red blood cells (anemia)
Please see prescribing information at https://www.novo-pi.com/sogroya.pdf
About the REAL4 study
The REAL4
(REversible ALbumin) study (NCT03811535) is part of the ongoing REAL
clinical study program and was designed to evaluate the efficacy and
safety of
Sogroya®
(somapacitan-beco) injection in children with growth hormone deficiency
(GHD).2 REAL4 is a randomized, open-label,
active-controlled parallel-group phase 3 trial, comprised of a
52-week main phase followed by a three-year extension
period.2 Two hundred growth hormone (GH) treatment-naïve,
prepubertal children with GHD were randomly assigned in a 2:1 ratio
to receive weekly subcutaneous injection of 0.16 mg/kg/week
Sogroya®
(n=132) or daily subcutaneous injection of 0.034 mg/kg/day
somatropin (n=68).2 The primary endpoint of REAL4 was
annualized height velocity after 52 weeks of treatment.2
About growth hormone deficiency (GHD)
GHD
is a rare disease estimated to affect approximately 1 in 3,500 to
10,000 children globally.10,11 It is characterized by an
insufficient amount of growth hormone (GH) circulating in the
body.3 GH is essential for growth, muscle and bone
strength, and GHD in children can result in slow growth from an
early age, resulting in a shorter stature than expected for their age/sex.3
About Sogroya®
Sogroya®
(somapacitan-beco) injection is a prescription human growth hormone
(GH) analog. Sogroya® was approved for the replacement of
endogenous growth hormone in adults with growth hormone deficiency
(AGHD) in the US on August 28, 2020.1
About Novo Nordisk
Novo Nordisk is a leading
global healthcare company that’s been making innovative medicines to
help people with diabetes lead longer, healthier lives for 100 years.
This heritage has given us experience and capabilities that also
enable us to drive change to help people defeat other serious chronic
diseases such as obesity and rare blood and endocrine disorders. We
remain steadfast in our conviction that the formula for lasting
success is to stay focused, think long-term and do business in a
financially, socially, and environmentally responsible way. With U.S.
headquarters in New Jersey and production and research facilities in
seven states, Novo Nordisk employs nearly 6,000 people throughout the
country. For more information, visit novonordisk-us.com, Facebook,
Instagram,
and Twitter.
References
- SOGROYA® (somapacitan-beco) injection, for
subcutaneous use [package insert]. Plainsboro, NJ: Novo Nordisk Inc;
2023.
- Miller BS, Blair JC, Rasmussen MH, et al. Weekly
Somapacitan is Effective and Well Tolerated in Children With GH
Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin
Endocrinol Metab. 2022;107(12):3378-3388.
doi:10.1210/clinem/dgac513.
- National Organization for Rare
Disorders. Growth Hormone Deficiency. Accessed: April 2023.
https://rarediseases.org/rare-diseases/growth-hormone-deficiency/
- Greenhill, C. Once-weekly growth hormone. Nat Rev
Endocrinol 13, 65 (2017). Accessed: April 2023.
https://doi.org/10.1038/nrendo.2016.220
- Höybye C,
Christiansen JS. Growth hormone replacement in adults - current
standards and new perspectives. Best Pract Res Clin Endocrinol
Metab. 2015;29(1):115-123. doi:10.1016/j.beem.2014.09.006.
- Brod M, Højbjerre L, Alolga SL, et al. Understanding Treatment
Burden for Children Treated for Growth Hormone Deficiency.
Patient. 2017;10(5):653-666.
doi:10.1007/s40271-017-0237-9.
- Christiansen JS, Backeljauw
PF, Bidlingmaier M, et al. Growth Hormone Research Society
perspective on the development of long-acting growth hormone
preparations. Eur J Endocrinol. 2016 Jun;174(6):C1-8. doi:
10.1530/EJE-16-0111. Epub 2016 Mar 23.
- Johansson E,
Nielsen AD, Demuth H, et al. Identification of Binding Sites on
Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone
Derivative. Biochemistry. 2020;59(14):1410-1419.
doi:10.1021/acs.biochem.0c00019
- Novo Nordisk. Data on
File.
- Stanley T. Diagnosis of growth hormone deficiency in
childhood. Curr Opin Endocrinol Diabetes Obes.
2012;19(1):47-52. doi:10.1097/MED.0b013e32834ec952
- Tornese
G.’ Growth hormone deficiency’ or rather ‘short stature unresponsive
to stimulation tests? Archives of Disease in Childhood Published
Online First: 27 January 2022. doi:
10.1136/archdischild-2021-323426
Further information
| Media: |
|
| Allison Schneider
(US) +1 732 513 4875
aocd@novonordisk.com
| MediaRelations@novonordisk.com |
Sogroya® is a registered
trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark
of Novo Nordisk A/S.
© 2023 Novo Nordisk All rights
reserved. US23SOM00168 April 2023