PARIS, July 27, 2016 /PRNewswire/ -- Sanofi
announced today that the U.S. Food and Drug Administration (FDA)
approved AdlyxinTM (lixisenatide), a once-daily mealtime
GLP-1 receptor agonist injection indicated as an adjunct to diet
and exercise for the treatment of adults with type 2 diabetes.
"The approval of Adlyxin reaffirms our continued commitment
to addressing the challenges faced by people living with diabetes
when trying to reach and maintain their individual blood glucose
(HbA1c) targets," said Peter
Guenter, Executive Vice President, Head, Global Diabetes
& Cardiovascular Business Unit, Sanofi. "We are pleased with
this approval, as it offers us the opportunity to continue helping
patients treated with basal insulin who remain
uncontrolled."
The approval of Adlyxin was based on FDA review of results from
the GetGoal clinical program and findings from the ELIXA trial,
which successfully addressed the FDA's request to demonstrate CV
safety. The GetGoal clinical program, which included 13
clinical trials involving more than 5,000 adults with type 2
diabetes worldwide, evaluated the safety and efficacy of
lixisenatide in adults with type 2 diabetes. All studies of the
GetGoal program successfully met the primary efficacy endpoint of
HbA1c reduction. The most common adverse events reported for
Adlyxin included nausea, hypoglycemia and vomiting.
Adlyxin will be available in a disposable pre-filled pen in a
single dose of 20 micrograms. Patients will also receive a
disposable pre-filled pen in a single dose of 10 micrograms that
they should initiate once daily for 14 days. On Day 15,
patients will increase dosage to 20 micrograms once daily.
Adlyxin is approved under the proprietary name,
Lyxumia® in more than 60 countries and marketed in over
40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand
Pharma A/S (NASDAQ OMX Copenhagen: ZEAL),
www.zealandpharma.com.
About Adlyxin
Adlyxin is a once-daily glucagon-like
peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult
patients with type 2 diabetes mellitus as an adjunct to diet and
exercise. GLP-1 is a peptide hormone that is released within
minutes after eating a meal. It is known to suppress glucagon
secretion from pancreatic alpha cells and stimulate
glucose-dependent insulin secretion by pancreatic beta cells.
Adlyxin increases glucose-dependent insulin release, decreased
glucagon secretion, and slows gastric
emptying.
Indication and Usage
What is Adlyxin (lixisenatide)
injection?
Adlyxin is an injectable prescription
medicine that may improve blood sugar (glucose)
control in adults with type 2 diabetes, when used with diet
and exercise.
- Adlyxin is not insulin and should not be used instead of a
long-acting insulin.
- Adlyxin is not for people with type 1 diabetes or people with
diabetic ketoacidosis.
- Adlyxin has not been studied in people with a history of
pancreatitis.
- Adlyxin has not been studied in people who use short-acting
insulin.
- It is not known if Adlyxin is safe and effective in
children.
Important Safety Information for Adlyxin (lixisenatide)
injection
What is the most important information I should know about
Adlyxin?
Do not share your Adlyxin pen with other people,
even if the needle has been changed. You may give other people a
serious infection, or get a serious infection from them.
Adlyxin can cause serious side effects,
including:
- inflammation of the pancreas (pancreatitis), which may be
severe and lead to death. Stop using Adlyxin 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 pain from your abdomen to your back.
Do not use Adlyxin if you:
- are allergic to lixisenatide or any of the other ingredients in
Adlyxin.
Symptoms of severe allergic reaction with Adlyxin may include
swelling of your face, lips, tongue, or throat, problems breathing
or swallowing, severe rash or itching, fainting or feeling dizzy,
and very rapid heartbeat.
Before using Adlyxin, tell your healthcare provider if
you:
- have or have had pancreatitis, stones in your gallbladder, or a
history of alcoholism.
- have or have had kidney problems.
- have severe problems with your stomach, such as delayed
emptying of your stomach (gastroparesis) or problems with digesting
food.
- are pregnant or breastfeeding or plan to become pregnant or
breastfeed. It is not known if Adlyxin will harm your unborn
baby.
Tell your healthcare provider about all the medicines you take,
including prescription medicines (especially antibiotics and birth
control pills) and over-the-counter medicines (especially
acetaminophen), vitamins, herbal supplements or other medicines to
treat diabetes, including sulfonylureas or insulin.
How should I use Adlyxin?
- Check the label on the pen each time you give your Adlyxin
injection to make sure you are using the correct medication.
- You must activate each Adlyxin pen before you use it for the
first time.
- Do not re-use or share your needles with other
people. You may give other people a serious infection, or get a
serious infection from them.
- Inject your dose of Adlyxin under the skin (subcutaneously) of
your abdomen, thigh, or upper arm. Do not inject into a
vein.
- Change (rotate) your injection sites within the area you chose
with each dose. Do not use the same spot for each injection.
What are the possible side effects of Adlyxin?
Adlyxin may cause serious side effects including:
- severe allergic reactions. Severe allergic
reactions can happen with Adlyxin. Stop taking Adlyxin and get
medical help right away if you have any symptoms of a severe
allergic reaction.
- low blood sugar (hypoglycemia). Your risk for getting
low blood sugar is higher if you use Adlyxin with another medicine
that can cause low blood sugar, such as a sulfonylurea or insulin.
The dose of your sulfonylurea or insulin medicine may need to be
lowered while you use Adlyxin. Signs and symptoms of low blood
sugar may include headache, drowsiness, weakness, hunger, fast
heartbeat, dizziness, confusion, irritability, sweating and feeling
jittery.
Talk with your healthcare provider about how to treat low
blood sugar.
The most common side effects of Adlyxin include:
- nausea, vomiting, headache, diarrhea and feeling dizzy.
Please click here for full Prescribing Information for Adlyxin:
http://products.sanofi.us/Adlyxin/Adlyxin.pdf.
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people
worldwide, with many managing the complex challenges of both.
Building on our portfolio evolution, heritage and expertise, Sanofi
has a focused business unit dedicated to delivering innovative,
value-based medicines and integrated solutions in these therapeutic
areas. We are committed to a collaborative approach that involves
strategic alliances with professional and patient associations,
research institutions and leaders in healthcare and other
industries, with the goal of advancing scientific knowledge,
driving the convergence of science and technology, helping to
improve outcomes and inspiring an evolution in care.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is
listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY).
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