BRIDGEWATER, N.J., Sept. 1, 2017 /PRNewswire-USNewswire/
-- Sanofi announced today that the U.S. Food and Drug
Administration (FDA) granted tentative approval for
Admelog® (insulin lispro injection) 100 Units/mL, a
rapid-acting human insulin analog. Admelog is indicated to improve
glycemic control in adults and children with diabetes mellitus.
The tentative approval is based on physicochemical, non-clinical
and clinical similarity to another insulin lispro 100 Units/mL as
currently approved in the U.S., including data from a clinical
development program involving more than 1,000 adults living with
type 1 or type 2 diabetes. Admelog is contraindicated during
episodes of hypoglycemia and in patients with hypersensitivity to
insulin lispro or one of its other ingredients.
With the tentative approval, the FDA concluded that Admelog met
all necessary regulatory requirements for approval in the U.S.,
pending any patent issues that are yet to be resolved.
"Sanofi is committed to broadening our portfolio of products
to help people living with diabetes manage their blood sugar,"
said Stefan Oelrich, Senior Vice
President and Head, Global Diabetes Franchise, Sanofi. "With
this tentative approval, we are now one step closer to offering
Admelog as an option for those who use rapid-acting
insulin."
The trade name "Admelog" was granted provisional approval by the
FDA and will be used in the U.S. when the product is made
available. Admelog was also granted marketing authorization under
the proprietary name, Insulin lispro Sanofi, by the European
Commission in July 2017.
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" 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