PLAINSBORO, N.J., Dec. 4, 2020 /PRNewswire/ -- Novo Nordisk
today announced that the U.S. Food and Drug Administration (FDA)
approved an updated label for
Saxenda® (liraglutide) injection 3 mg for use in
the treatment of obesity in adolescents (12–17 years) with a body
weight above 60 kg and an initial body mass index (BMI)
corresponding to 30 kg/m2 or greater for adults, as an
adjunct to reduced-calorie meals and increased physical activity.
Saxenda® was approved in 2014 for chronic weight
management in adults with a BMI ≥30 kg/m2, or ≥27
kg/m2 with at least one weight-related comorbidity, as
an adjunct to a reduced calorie meal plan and increased physical
activity.1
Over the last 20 years, the global prevalence of children and
adolescents with excess weight has doubled from 1 in 10 to 1 in
5.2 Research also shows that when both parents have
excess weight, 80% of their children will have
obesity.3 However, current treatment options for
this population are limited, highlighting a considerable and
growing need for additional treatment strategies.4
"New options to treat adolescents who live with obesity can
bring much-needed hope to families and help address this growing
epidemic," said Dr. Aaron Kelly,
Professor of Pediatrics and co-director of the Center for Pediatric
Obesity Medicine at the University of
Minnesota. "With up to 90 percent of adolescents with
obesity likely to have it as adults and thus at increased risk for
developing weight-related complications, it's important to address
weight care and offer support early
on.3,5 I'm encouraged that healthcare
providers now have another tool in developing a personalized,
complete care plan to help adolescents lose weight and keep it
off."
The safety and efficacy of Saxenda® as a treatment
for adolescents with obesity is supported by data from a phase 3a
trial published earlier this year in the New England Journal of
Medicine. The 56-week clinical trial investigated the effects
of Saxenda® compared to placebo for weight management in
251 patients aged 12-17 living with obesity as an adjunct to
lifestyle therapy, defined as counselling in healthy nutrition and
physical activity for weight loss. In the trial, the primary
endpoint was change from baseline in Body Mass Index (BMI) Standard
Deviation Score (SDS) at week 56.6
The data demonstrated a significant reduction in BMI-SDS, as
well as reductions in BMI, mean body weight, and other
weight-related endpoints vs. placebo in adolescents with obesity
when using Saxenda® as an adjunct to lifestyle therapy.
Adverse events seen in an adolescent population were similar to
those observed in adults. The most common adverse reactions were
gastrointestinal events, including nausea, vomiting and
diarrhea.6
"The rise in adolescent obesity is contributing to a
public health crisis, and it poses a real challenge for healthcare
professionals due to the limited treatment options available," said
Mads Krogsgaard Thomsen, executive
vice president and chief scientific officer of Novo Nordisk. "We
are proud to be able to offer a new treatment option for
adolescents with obesity and their families in the US, as the FDA
approval marks another significant milestone for
Saxenda®."
What is Saxenda®?
Saxenda® (liraglutide) injection 3 mg is an
injectable prescription medicine used for adults with excess weight
(BMI ≥27) who also have weight-related medical problems or obesity
(BMI ≥30), and children aged 12-17 years with a body weight above
132 pounds (60 kg) and obesity to help them lose weight and keep
the weight off. Saxenda® should be used with a
reduced calorie diet and increased physical activity.
- Saxenda® and Victoza® have the
same active ingredient, liraglutide, and should not be used
together or with other GLP-1 receptor agonist medicines.
- It is not known if Saxenda® is safe and effective
when taken with other prescription, over-the-counter medicines, or
herbal weight-loss products.
- It is not known if Saxenda® is safe and
effective in children under 12 years of age.
- It is not known if Saxenda® is safe and
effective in children aged 12 to 17 years with type 2
diabetes.
Important Safety Information
Do not share your Saxenda pen with others even if the needle
has been changed. You may give other people a serious infection or
get a serious infection from them.
What is the most important information I should know about
Saxenda®?
Serious side effects may happen in
people who take Saxenda®, including:
Possible thyroid tumors, including cancer. Tell your
health care professional if you get a lump or swelling in your
neck, hoarseness, trouble swallowing, or shortness of breath. These
may be symptoms of thyroid cancer. In studies with rats and mice,
Saxenda® and medicines that work like
Saxenda® caused thyroid tumors, including thyroid
cancer. It is not known if Saxenda® will cause thyroid
tumors or a type of thyroid cancer called medullary thyroid
carcinoma (MTC) in people.
Do not use Saxenda® if you or any of
your family have ever had MTC, or if you have an endocrine system
condition called Multiple Endocrine Neoplasia syndrome type 2
(MEN 2).
Who should not use Saxenda®?
Do not use
Saxenda® if:
- you or any of your family have ever had MTC or if you have MEN
2.
- you are allergic to liraglutide or any of the ingredients in
Saxenda®.
- you are pregnant or plan to become pregnant. Saxenda may harm
your unborn baby.
Before taking Saxenda®, tell your health care
provider about all of your medical conditions, including if
you:
- are taking certain medicines called GLP-1 receptor
agonists.
- have severe problems with your stomach, such as slowed emptying
of your stomach (gastroparesis) or problems with digesting
food.
- have or have had problems with your pancreas, kidneys or
liver.
- have or have had depression or suicidal thoughts, or mental
health issues.
- are breastfeeding or plan to breastfeed. It is not known if
Saxenda® passes into your breast milk. You and your
health care provider should decide if you will use
Saxenda® or breastfeed.
Tell your health care provider about all the medicines you
take, including prescription, over-the-counter medicines,
vitamins, and herbal supplements. Saxenda® slows stomach
emptying and can affect medicines that need to pass through the
stomach quickly. Saxenda® may affect the way some
medicines work and some other medicines may affect the way
Saxenda® works. Tell your health care provider if you
take diabetes medicines, especially insulin and sulfonylurea
medicines.
How should I use Saxenda®?
- Inject your dose of Saxenda® under the skin
(subcutaneously) in your stomach area (abdomen), upper leg (thigh),
or upper arm, as instructed by your health care provider. Do not
inject into a vein or muscle.
What are the possible side effects of
Saxenda®?
Saxenda® may cause
serious side effects, including:
- inflammation of the pancreas (pancreatitis). Stop using
Saxenda® and call your healthcare provider right away if
you have severe pain in your stomach area (abdomen) that will not
go away, with or without vomiting. You may feel the pain from your
stomach area (abdomen) to your back.
- gallbladder problems. Saxenda® may cause
gallbladder problems, including gallstones. Some gallbladder
problems need surgery. Call your health care provider if you have
any of the following symptoms: pain in your upper stomach
(abdomen), fever, yellowing of your skin or eyes (jaundice), or
clay-colored stools.
- increased risk of low blood sugar (hypoglycemia) in adults
with type 2 diabetes who also take medicines to treat type 2
diabetes such as sulfonylureas or insulin.
- risk of low blood sugar (hypoglycemia) in children who are
12 years of age and older without type 2 diabetes.
- Signs and symptoms of low blood sugar may include: shakiness,
sweating, headache, drowsiness, weakness, dizziness, confusion,
irritability, hunger, fast heartbeat, and feeling jittery. You
should check your blood sugar before you start taking
Saxenda® and while you take Saxenda®.
- increased heart rate. Saxenda® can increase
your heart rate while you are at rest. Your health care provider
should check your heart rate while you take Saxenda®.
Tell your health care professional if you feel your heart racing or
pounding in your chest and it lasts for several minutes.
- kidney problems (kidney failure). Saxenda®
may cause nausea, vomiting, or diarrhea leading to loss of fluids
(dehydration). Dehydration may cause kidney failure, which can lead
to the need for dialysis. This can happen in people who have never
had kidney problems before. Drinking plenty of fluids may reduce
your chance of dehydration. Call your health care provider right
away if you have nausea, vomiting, or diarrhea that does not go
away, or if you cannot drink liquids by mouth.
- serious allergic reactions. Stop using
Saxenda® and get medical help right away if you have any
symptoms of a serious allergic reaction including swelling of your
face, lips, tongue, or throat, fainting or feeling dizzy, very
rapid heartbeat, problems breathing or swallowing, or severe rash
or itching.
- depression or thoughts of suicide. You should pay
attention to any mental changes, especially sudden changes, in your
mood, behaviors, thoughts, or feelings. Call your health care
provider right away if you have any mental changes that are new,
worse, or worry you.
The most common side effects of Saxenda® in adults
include nausea, diarrhea, constipation, vomiting, injection
site reaction, low blood sugar (hypoglycemia), headache, tiredness
(fatigue), dizziness, stomach pain, and change in enzyme (lipase)
levels in your blood. Additional common side effects in children
are fever and gastroenteritis.
Please see Prescribing Information and Medication Guide for
Saxenda® at www.novo-pi.com/saxenda.pdf.
About the phase 3 trial (NCT02918279)
The trial investigated the effect of Saxenda®
(liraglutide 3.0 mg or maximum tolerated dose) compared to placebo
for weight management in 251 adolescents (aged 12 to <18 years)
living with obesity as an adjunct to lifestyle therapy.6
The trial included a 12-week run-in period of lifestyle therapy, a
56-week treatment period (including dose escalation over 4 to 8
weeks) on Saxenda® or placebo and a 26-week follow-up
period without Saxenda® or placebo.6 All
participants received lifestyle therapy beginning with the run-in
period and during the 56-week treatment period and 26-week
follow-up period.6 The phase 3a trial was a
post-marketing requirement of the FDA under the Pediatric Research
Equity Act (PREA), which aims to ensure treatments are safe and
effective for children and adolescents.7,8
About
Saxenda®
Saxenda®
(liraglutide) injection 3.0 mg is a once-daily glucagon-like
peptide-1 (GLP-1) receptor agonist with 97% similarity to naturally
occurring human GLP-1, a hormone that is involved in appetite
regulation and food intake.1 Like human GLP-1,
Saxenda® is believed to work in areas of the brain
involved in appetite regulation, including the
hypothalamus.1 Saxenda® for use in
adults with obesity was evaluated in the SCALE (Satiety and
Clinical Adiposity – Liraglutide Evidence) clinical trial program.
Since launch in 2015, more than 1.5 million patients have been
treated with Saxenda® globally.7
Saxenda® is already indicated in the US for chronic
weight management in adults with a BMI ≥30 kg/m2, or ≥27
kg/m2 with one or more weight-related
comorbidities, as an adjunct to a reduced-calorie meal plan and
increased physical activity.1
About obesity
Obesity is a chronic, progressive and
misunderstood disease that requires long-term medical
management.9,10 One key misunderstanding is that this is
a disease of willpower, when in fact there is underlying biology
that prevents people from achieving long-term weight
loss.11 Obesity is influenced by a variety of factors,
including genetics, appetite signals, behavior and the
environment.11 It is a gateway disease and is associated
with at least 60 other health conditions.12 The current
COVID-19 pandemic has highlighted that obesity also increases the
risk for severe illness and hospitalization due to
COVID-19.13,14 In the
United States, more than 42% of adults live with
obesity.15
About adolescent obesity
Adolescents with obesity are also more likely to develop
weight-related diseases, like diabetes and cardiovascular diseases,
at a younger age.16 Just like other chronic
diseases, obesity requires long-term management.9,10
Research shows that when both parents have excess weight, about 80%
of their children will have obesity.3 Globally, more
than 124 million children and adolescents have
obesity.17 In the United States, nearly 1 in 5, or
about 13.7 million, children and adolescents have
obesity.18,19
About Novo Nordisk
Novo Nordisk is a global
healthcare company that's been making innovative medicines to help
people with diabetes lead longer, healthier lives for 95 years.
This heritage has given us experience and capabilities that also
enable us to help people defeat other serious diseases including
obesity, hemophilia and growth 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 six states, Novo Nordisk employs nearly
6,000 people throughout the country. For more information,
visit novonordisk.us,
Facebook, Instagram and
Twitter.
References
1 US Food and Drug Administration (FDA).
Saxenda® Prescribing Information. December
2020.
2 UNICEF. The state of the world's children
2019. Available at:
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accessed: November 2020.
3 Lifshitz F. Obesity in Children. J Clin Res
Pediatr Endocrinol. 2008 Dec; 1(2): 53–60
4 Cardel M, Jastreboff A, Kelly A. Treatment of
Adolescent Obesity in 2020. JAMA. 2019; 322:1707–1708.
5 Gordon-Larsen P, The NS, Adair LS.
Longitudinal Trends in Obesity in the
United States from Adolescence to the Third Decade of Life.
Obesity. 2010; 18 (9): 1801-1804
6 Kelly A, Auerbach P, Barrientos-Perez M. A
Randomized, Controlled Trial of Liraglutide for Adolescents with
Obesity. Available at:
https://www.nejm.org/doi/full/10.1056/NEJMoa1916038. NEJM.
2020;DOI: 10.1056/NEJMoa1916038
7 Novo Nordisk. Data on File.
8 Center for Drug Evaluation and Research.
Pediatric Research Equity Act. U.S. Food and Drug Administration.
https://www.fda.gov/drugs/development-resources/pediatricresearch-equity-act-prea.
Last accessed: November 2020.
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Policies on Second Day of Voting at Annual Meeting. Obesity as a
Disease. Available at:
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Last accessed: November 2020.
10 Bray GA, Kim KK, Wilding JPH. World Obesity
Federation. Obesity: a chronic relapsing progressive disease
process. A position statement of the World Obesity Federation.
ObesRev. 2017;18(7):715-723. doi:10.1111/obr.12551.
11 Wright SM, Aronne LJ. Causes of obesity.
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12 Bays HE, McCarthy W, Christensen S, et al.
Obesity Algorithm, presented by the Obesity Medicine Association.
Available at: https://obesitymedicine.org/obesity-algorithm/. Last
Accessed: November 2020.
13 Finer N, Garnett SP and Bruun JM. COVID-19
and obesity. Clin Obes. 2020;
10:e12365.
14 Ryan DH, Ravussin E and Heymsfield S. COVID
19 and the Patient with Obesity - The Editors Speak Out.
Obesity. 2020; 28:847.
15 Centers for Disease Control and Prevention.
Adult Obesity Facts. Available at:
https://www.cdc.gov/obesity/data/adult.html. Updated June 29, 2020. Last accessed: November 2020.
16 World Health Organization. Childhood
overweight and obesity. Available at:
https://www.who.int/dietphysicalactivity/childhood/en/. Last
accessed: November 2020.
17 World Health Organization. Obesity and
overweight. Available at:
https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight.
Last accessed: November 2020.
18 Centers for Disease Control and Prevention.
Childhood Overweight and Obesity. Available at:
https://www.cdc.gov/obesity/childhood/index.html. Updated
September 11, 2018. Last accessed:
November 2020.
19 Centers for Disease Control and Prevention.
Childhood Obesity Facts. Available at:
https://www.cdc.gov/obesity/data/childhood.html. Updated
June 24, 2019. Last accessed:
November 2020.
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