PARIS, Jan. 4, 2017 /PRNewswire-USNewswire/
-- Sanofi announced today that Soliqua™ 100/33 (insulin
glargine 100 Units/mL & lixisenatide* 33 mcg/mL
injection) is now available by prescription in U.S. pharmacies.
Soliqua 100/33 is indicated for the treatment of adults with type 2
diabetes inadequately controlled on basal insulin (less than 60
Units daily) or lixisenatide.
"We are encouraged by the potential of Soliqua 100/33, which
has demonstrated superior HbA1c lowering versus Lantus," said
Peter Guenter, Executive Vice
President, Head, Global Diabetes & Cardiovascular Business
Unit, Sanofi. "By offering Soliqua 100/33 – a product containing
both a basal insulin and a GLP-1 therapy – at a competitive price
while facilitating patient access, we believe we are providing
value to patients and the healthcare system."
In the labeled clinical trial, once-daily Soliqua 100/33
demonstrated statistical superiority for the change in HbA1c from
baseline to week 30 (p<0.0001) versus Lantus®, the
most prescribed basal insulin in the world.1,2,3 The
most common side effects reported in the clinical program included
low blood sugar, nausea, stuffy or runny nose and sore throat,
diarrhea, upper respiratory tract infection and headache. Soliqua
100/33 is delivered in a single pre-filled SoloStar pen with a dose
range covering from 15 to 60 Units and two starting doses to
support patients' insulin needs. Soliqua 100/33 was approved by the
U.S. Food and Drug Administration (FDA) on November 21, 2016.
The daily Wholesale Acquisition Cost (WAC) price of Soliqua
100/33 is $127 for a 300 Unit pen,
which equals $19.90 per day at the
average final dose of 47 Units used in the labeled clinical
trial.
Sanofi is offering Soliqua 100/33 at a $0 co-pay** for eligible U.S. patients
with commercial insurance and is working to secure coverage for
Soliqua 100/33 on health plans nationwide. Sanofi is also offering
a tailored support program, Soliqua 100/33 COACH, at no cost to
adults living with type 2 diabetes who have been prescribed Soliqua
100/33 by their doctor. For additional information, please visit
www.soliqua100-33.com.
"Healthcare professionals need a broad range of treatments to
individualize a patient's diabetes care, particularly for the many
adults living with diabetes who continue to face challenges in
controlling their blood sugar levels even after treatment with
basal insulin," said George
Grunberger, M.D., FACP, FACE, Chairman, Grunberger Diabetes
Institute. "This combination product provides a new option for
many patients uncontrolled on basal insulin therapy or
lixisenatide."
What is SOLIQUA™ 100/33 (insulin glargine 100
Units/mL and lixisenatide 33 mcg/mL injection)?
SOLIQUA 100/33 is an injectable prescription medicine that
contains 2 diabetes medicines, insulin glargine 100 Units/mL and
lixisenatide, that may improve blood sugar (glucose) control in
adults with type 2 diabetes, when used with diet and exercise in
people who are not controlled with long-acting (basal) insulin
(less than 60 units daily) or lixisenatide.
- 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, diabetic
ketoacidosis, or who have a stomach problem that causes slow
emptying (gastroparesis).
- It has not been studied together with short-acting
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.
SOLIQUA 100/33 can cause serious side effects,
including inflammation of the pancreas, which may be
life-threatening.
Before using SOLIQUA 100/33, tell your doctor if you have
had:
- pancreatitis
- a history of alcoholism
- stones in your gallbladder (cholelithiasis)
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) or if you are allergic to insulin glargine,
lixisenatide, or any of the other ingredients in SOLIQUA
100/33.
Tell your healthcare provider about all your medical
conditions, including if you:
- have or have had symptoms of acute pancreatitis, stones in your
gallbladder, or a history of alcoholism.
- have or have had liver or kidney problems.
- have heart failure or other heart problems. If you have heart
failure, it may get worse while you take TZD
(thiazolidinediones).
- have severe problems with your stomach, such as slowed emptying
of your stomach or problems digesting food.
- are pregnant or plan to become pregnant. It is not known if
SOLIQUA 100/33 will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SOLIQUA 100/33 passes 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
How should I use SOLIQUA 100/33?
- Do not take more than 60 units of SOLIQUA 100/33 each
day. If you take too much, it can cause severe nausea and
vomiting. Do not take SOLIQUA 100/33 with other GLP-1 receptor
agonists. If you take too much SOLIQUA 100/33, call your healthcare
provider or go to the nearest hospital emergency room right
away.
- Only use SOLIQUA 100/33 that is clear, colorless to almost
colorless. If you see small particles, return it to your pharmacy
for replacement.
- Do not mix SOLIQUA 100/33 in any other type of insulin
or liquid medicine prior to injection.
- 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.
SOLIQUA 100/33 may cause serious side effects,
including:
- Serious allergic reactions. Severe allergic reactions
can happen with SOLIQUA 100/33. Stop taking it and get help right
away if you have any symptoms of a severe allergic reaction.
Symptoms may include swelling of your face, 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
- confusion
- weakness
- irritability
- hunger
- sweating
- fast heartbeat
- feeling jittery
- 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, sudden weight gain.
The most common side effects of SOLIQUA 100/33 may
include:
- low blood sugar (hypoglycemia)
- allergic reactions
- nausea
- diarrhea
- headache
- upper respiratory tract infection
- stuffy or runny nose and sore throat
Nausea and diarrhea usually happen more often when you start
using SOLIQUA 100/33.
Please click here for full Prescribing Information for SOLIQUA
100/33 (insulin glargine & lixisenatide injection) 100 Units/mL
& 33 mcg/mL: www.soliqua100-33.com.
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 Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
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", "looks
forward" 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,
2015. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
* Lixisenatide was in-licensed from Zealand Pharma
A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com.
** With the SOLIQUA 100/33 Savings Card, patients may
be eligible for the $0 CO-PAY offer
for the next 12 months. Restrictions apply. This offer is for
commercially insured patients and is not valid for prescriptions
covered by or submitted for reimbursement under Medicare, Medicaid,
VA, DOD, or TRICARE, or similar federal or state programs including
any state pharmaceutical programs. Void where prohibited by law.
Savings card carries maximum savings of $700 off per pack for the duration of the
program. Savings may vary depending on patient's out-of-pocket
costs. Upon registration, patient receives all program details.
Sanofi US reserves the right to rescind, revoke, or amend the
program without notice.
References
- Data on file: IMS Q_Global Q4/2015, V.Kircher.
- Rosenstock J, et al. Presentation 186-O presented at American
Diabetes Association (ADA) 76th Scientific Sessions, New Orleans, LA, U.S., 2016. Available from
Date accessed: November 2016.
- Aroda V, et al. Presentation 238-O presented at American
Diabetes Association (ADA) 76th Scientific Sessions, New Orleans, LA, U.S., 2016. Available from
Date accessed: November 2016.
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SOURCE Sanofi