PARIS, Dec. 11, 2017 /PRNewswire/ -- The U.S.
Food and Drug Administration (FDA) has approved Sanofi's
Admelog®, the first follow-on insulin lispro to help
people living with diabetes manage blood sugar levels at
mealtime.
"Sanofi has a deep heritage and
broad experience in providing treatments for people living with
diabetes. Complementing our existing insulin portfolio, Admelog
will offer a more affordable option for those who require control
of their blood sugar levels at mealtime," said Stefan Oelrich, Executive Vice President
and Head, Global Diabetes and Cardiovascular, Sanofi. "The approval
of Admelog is an important milestone for Sanofi in our mission to
serve patients living with chronic diseases such as
diabetes."
Admelog is a rapid-acting insulin similar to
Humalog®, another insulin lispro 100 Units/mL, currently
approved in the U.S. The Admelog clinical development program
involved more than 1,000 adults living with type 1 or type 2
diabetes. Admelog will be available in both vials and the SoloStar
pen, which is the most-used disposable insulin pen platform in the
U.S.
Admelog was also granted marketing authorization as a
biosimilar, under the proprietary name, Insulin lispro
Sanofi®, by the European Commission in July 2017.
What is Admelog (insulin lispro injection)?
Prescription Admelog is a fast-acting human insulin used to
improve blood sugar control in adults with Type 2 diabetes and
adults and children (3 years and older) with Type 1 diabetes.
Important Safety Information for Admelog (insulin lispro
injection)
Do not use Admelog if you have low blood sugar or if you are
allergic to insulin lispro or any of the other ingredients in
Admelog.
Before starting Admelog, tell your doctor about all your medical
conditions, including if you have liver or kidney problems, if you
are pregnant or planning to become pregnant or if you are
breastfeeding or planning to breastfeed.
Heart failure can occur if you are taking insulin together with
pills called TZDs (thiazolidinediones), even if you have never had
heart failure or other heart problems. If you have heart
failure, it may get worse while you take TZDs with Admelog.
Your treatment with TZDs and Admelog may need to be changed or
stopped by your doctor if you have new or worsening heart
failure. Tell your doctor if you have any new or worsening
symptoms, including:
- Shortness of breath
- Sudden weight gain
- Swelling of your ankles or feet
Tell your doctor about all the medications you take, including
OTC medicines, vitamins, supplements, and herbal supplements.
When used as a mealtime insulin, Admelog should be taken within
15 minutes before a meal or immediately after a meal. Test
your blood sugar levels as directed by your doctor when using
Admelog. Do not change your dose or type of insulin without
talking to your doctor. Any change of insulin should be made
cautiously and only under medical supervision.
Do not share needles, insulin pens, or syringes with others,
even if the needle is changed. Do NOT reuse needles.
Check your insulin label to verify that you have the correct
insulin before each injection. Admelog must only be used if
the solution is clear and colorless with no particles visible.
While using Admelog, do not drive or operate heavy machinery
until you know how Admelog affects you. Do not drink alcohol
or use medicines that contain alcohol.
The most common side effect of any insulin, including
Admelog, is low blood sugar (hypoglycemia), which may be serious
and life-threatening. Symptoms of serious low blood sugar
may include shaking, sweating, fast heartbeat, and blurred
vision.
Admelog may cause severe allergic reactions that can lead to
death. Get medical help right away if you have:
- A rash over your whole body
- Trouble breathing
- Fast heartbeat
- Feeling faint
- Sweating
Admelog may have additional side effects including low potassium
and injection site reactions which may include change in fat
tissue, skin thickening, redness, swelling and itching.
Important Safety Information for Admelog (insulin lispro
injection) SoloStar
Admelog SoloStar is a disposable prefilled insulin pen.
Talk to your doctor about proper injection technique and follow
instructions in the Instruction Leaflet that comes with the
pen.
Please see full Prescribing Information.
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
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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,
2016. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
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SOURCE Sanofi