BRIDGEWATER, N.J., Feb. 27,
2019 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has approved the expanded use of
Soliqua® 100/33 (insulin glargine and lixisenatide
injection) 100 Units/mL and 33 mcg/mL. Previously approved for use
as an add-on to diet and exercise in adults with type 2 diabetes
who are uncontrolled on long-acting insulin or lixisenatide,
Soliqua 100/33 can now also be prescribed for patients uncontrolled
on oral antidiabetic medicines.
"Many people living with type 2
diabetes are uncontrolled on diet and exercise alone and could
require additional interventions to help lower their blood sugar
levels," said Michelle Carnahan, North America Head of
Primary Care, Sanofi. "This FDA decision marks the first
combination insulin and GLP-1 injectable medicine approved for
adults living with type 2 diabetes who are uncontrolled with diet
and exercise, potentially providing them access to an option that
can help them achieve their treatment goals."
The FDA approval was based on data from the LixiLan-O clinical
trial which showed, in adults with type 2 diabetes uncontrolled
with metformin and/or a second oral antidiabetic therapy, that
treatment with Soliqua 100/33 led to significantly greater
reductions in blood sugar levels compared with insulin glargine and
lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001). In
addition, significantly more patients reached their target blood
sugar levels with Soliqua 100/33 (74%) compared with insulin
glargine (59%) or lixisenatide (33%). Low blood sugar events were
similar between Soliqua 100/33 (25.6%) and insulin glargine
(23.6%), but were lower with lixisenatide (6.4%). The most common
adverse events generally at the beginning of treatment in the
Soliqua 100/33 arm were nausea (9.6%) and vomiting (3.2%).
Sanofi will continue offering its savings program for Soliqua
100/33 which can limit out-of-pocket expenses sometimes to
$0 for all commercially insured
patients regardless of formulary status on an insurance plan or
income level. For more information about this program,
visit www.soliqua100-33.com.
About Soliqua 100/33
Soliqua 100/33 is an injectable prescription medicine that
contains 2 diabetes medicines, insulin glargine and lixisenatide,
which may improve blood sugar (glucose) control in adults with type
2 diabetes when used with diet and exercise.
- It has not been studied in people with a history of
pancreatitis.
- It is not recommended for people who also take lixisenatide or
other medicines called GLP-1 receptor agonists.
- It is not for use in people with type 1 diabetes, or people
with diabetic ketoacidosis.
- It has not been studied in people who have a stomach problem
that causes slow emptying (gastroparesis) and is not for people
with slow emptying of the stomach.
- It has not been studied in people who also take a short-acting
(prandial) insulin.
- It is not known if Soliqua 100/33 is safe and effective in
children under 18 years of age.
Important Safety Information for Soliqua® 100/33 (insulin
glargine and lixisenatide injection) 100 Units/mL and 33
mcg/mL
What is the most important information I should know
about Soliqua 100/33?
Do not share your Soliqua 100/33 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.
Soliqua 100/33 can cause serious side
effects, including inflammation of the pancreas, which may
be severe and lead to death.
Before using Soliqua 100/33, tell your
doctor if you have had pancreatitis, stones in your gallbladder
(cholelithiasis), or a history of alcoholism. These medical
problems may make you more likely to get pancreatitis.
Stop taking Soliqua 100/33 and call your healthcare provider
right away if you have pain in your stomach area (abdomen) that is
severe, and will not go away. The pain may be felt in the back
area. The pain may happen with or without vomiting.
Who should not use Soliqua 100/33?
Do not use Soliqua 100/33 if you:
- are having an episode of low blood sugar (hypoglycemia)
- are allergic to insulin glargine, lixisenatide, or any of the
ingredients in Soliqua 100/33. Symptoms of a severe allergic
reaction with Soliqua 100/33 may include swelling of the face,
lips, tongue, or throat, fainting or feeling dizzy, problems
breathing or swallowing, very rapid heartbeat, severe rash or
itching, or low blood pressure.
Before using Soliqua 100/33, tell your
healthcare provider about all your medical conditions, including if
you:
- have or have had problems with your pancreas, your kidneys, or
your liver, stones in your gallbladder, or a history of
alcoholism.
- have heart failure or other heart problems. If you have heart
failure, it may get worse while you take thiazolidinediones
(TZDs).
- have severe problems with your stomach, such as slowed emptying
of your stomach or problems digesting food.
- are taking certain medicines called glucagon-like peptide 1
receptor agonists (GLP-1 receptor agonists).
- have had an allergic reaction to a GLP-1 receptor agonist.
- are pregnant or breastfeeding or plan to become pregnant or to
breastfeed. It is not known if Soliqua 100/33 will harm your unborn
baby or pass into your breast milk.
Tell your healthcare provider about all the medicines you
take, including all prescription and over-the-counter
medicines, vitamins, and herbal supplements. Soliqua 100/33 may
affect the way some medicines work. Before using
Soliqua 100/33, talk to your healthcare provider about
low blood sugar and how to manage it.
How should I use Soliqua 100/33?
- Do not change your dose without first talking to your
healthcare provider.
- Check the pen label each time you inject to make sure you are
using the correct medicine.
- Do not take more than 60 units of Soliqua
100/33 each day. Do not take Soliqua 100/33 with other
GLP-1 receptor agonists.
- Only use Soliqua 100/33 that is clear and colorless to almost
colorless. If you see small particles, return it to your pharmacy
for replacement.
- Do not remove Soliqua 100/33 from the pen with a
syringe.
- Do not re-use or share needles with other people. You may
give other people a serious infection, or get a serious infection
from them.
- Check your blood sugar levels. Ask your healthcare
provider what your blood sugar should be and when you should
check.
What are the possible side effects of Soliqua
100/33?
Soliqua 100/33 may cause serious side
effects, including:
- Serious allergic reactions. Stop taking Soliqua
100/33 and get help right away if you have any symptoms of a
serious allergic reaction, including swelling of your face, lips,
tongue, or throat, problems breathing or swallowing, severe rash or
itching, fainting or feeling dizzy, and very rapid heartbeat.
- Low blood sugar (hypoglycemia). Your risk for getting low
blood sugar is higher if you take another medicine that can cause
low blood sugar. Signs and symptoms of low blood sugar may
include headache, dizziness, drowsiness, sweating, weakness,
irritability, hunger, blurred vision, fast heartbeat, feeling
jittery, confusion, and anxiety.
- Kidney problems (kidney failure). In people who
have kidney problems, diarrhea, nausea, and vomiting may cause a
loss of fluids (dehydration), which may worsen kidney
problems.
- Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called
TZDs (thiazolidinediones) with Soliqua 100/33 may cause heart
failure in some people. This can happen even if you have never had
heart failure or heart problems before. If you already have heart
failure, it may get worse while you take TZDs with Soliqua 100/33.
Tell your healthcare provider if you have any new or worse symptoms
of heart failure, including shortness of breath, swelling of your
ankles or feet, or sudden weight gain. Treatment with TZDs and
Soliqua 100/33 may need to be adjusted or stopped if you have
new or worse heart failure.
The most common side effects of Soliqua 100/33
include low blood sugar (hypoglycemia), nausea, diarrhea,
upper respiratory infection, stuffy or runny nose, and
headache. Nausea and diarrhea usually happen more often when
you first start using Soliqua 100/33.
Click here for Full Prescribing Information for Soliqua
100/33.
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Media Relations
Contact
|
Investor Relations
Contact
|
Nicolas
Kressmann
|
George
Grofik
|
Tel.: +1 732 532
5318
|
Tel.: +33 (0)1 53 77
45 45
|
nicolas.kressmann@sanofi.com
|
ir@sanofi.com
|
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2017. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
View original
content:http://www.prnewswire.com/news-releases/fda-expands-indication-for-soliqua-10033-300803620.html
SOURCE Sanofi