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Sanofi : Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

Sanofi New Drug Application for Lixisenatide
Accepted for Review by FDA

- First New Drug Application for a GLP-1 receptor agonist to include CV
outcomes data -

Paris, France - September 29th, 2015
Sanofiannounced today that the U.S. Food and Drug Administration (FDA) has
accepted for filing the New Drug Application (NDA) for lixisenatide, an
investigational once-daily prandial GLP-1 receptor agonist for the treatment
of adults with type 2 diabetes mellitus (T2DM).

"The FDA filing notification for lixisenatide is an important milestone for
said Pierre Chancel, Senior Vice President, Head of Global Diabetes at Sanofi.
"Sanofi's integrated portfolio of
marketed products
provides treatment, monitoring and support at every stage of the diabetes
journey. Lixisenatide is a critical element of this portfolio, and we look
forward to working with the FDA during the review process with the goal of
bringing lixisenatide to patients in the U.S

The NDA submission for lixisenatide is based on results from the GetGoal
clinical program1,2and includes findings from the recently-completed ELIXA
study,3the first completed long-term CV outcomes study of a GLP-1 receptor
agonist. The GetGoal Phase III clinical program enrolled more than 5,000
patients worldwide, evaluating the safety and efficacy of lixisenatide,
including its treatment effect on HbA1c, post-prandial glucose and body
weight in adults with T2DM. The ELIXA trial evaluated the cardiovascular
safety of lixisenatide versus standard of care in more than 6,000 adults with
T2DM and high CV risk (i.e., patients who have recently experienced a
spontaneous acute coronary syndrome event).

The proprietary name for lixisenatide in the United States is under
consideration. Lyxumia®is the proprietary name approved by the European
Medicines Agency and other health authorities.

About Lixisenatide

Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist
(GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus.
GLP-1 is a naturally-occurring 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.

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL),, and was approved in Europe in 2013 for the
treatment of adults with type 2 diabetes mellitus to achieve glycemic control
in combination with oral glucose-lowering medicinal products and/or basal
insulin when these, together with diet and exercise, do not provide adequate
glycemic control. Lixisenatide is currently approved in over 60 countries
worldwide for the treatment of adults with type 2 diabetes, with commercial
launches in most EU countries, Japan, Brazil, Mexico and other markets.
Lixisenatide is an investigational product in the U.S.

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by
delivering innovative, integrated and personalized solutions. Driven by
valuable insights that come from listening to and engaging with people living
with diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services, and devices including blood glucose monitoring systems.
Sanofi markets injectable, inhaled and oral medications for people with type
1 or type 2 diabetes.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi has core strengths
in diabetes solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in Paris
(EURONEXT:SAN) and in New York (NYSE:SNY).


1. Bain SC. Diabetes Therapy 2014 5(2): 367-383, DOI
2. Rosenstock J, et al. Abstract 107-LB presented at ADA 75th Scientific
Sessions, Boston, U.S., 2015. Date accessed: June 2015. (GetGoal Duo 2).
3. Pfeffer MA, et al. Symposium - The Evaluation of Lixisenatide in Acute
Coronary Syndrome-The Results of ELIXA. Presented at ADA 75th Scientific
Sessions, Boston, U.S., 2015.

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 and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services, product
development and potential, and statements regarding future performance.
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, the uncertainties inherent in
research and development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or biological
application that may be filed for any such product candidates as well as
their decisions regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates, the absence
of guarantee that the product candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, the Group's ability to benefit from external growth
opportunities, trends in exchange rates and prevailing interest rates, the
impact of cost containment policies and subsequent changes thereto, the
average number of shares outstanding as well as those 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, 2014. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.

| Contacts: Investor Relations |
| |
| Sébastien Martel |
|Media Relations Tel.: + (33) 1 53 77 45 45 |
| |
|Jack Cox |
|Tel.: + (33) 1 53 77 46 46 |
| |
| Global Diabetes Communications U.S. Diabetes Communications |
| |
|Philip McNamara Susan Brooks |
|Tel.: +1 908 981 5497 Office: +1 908 981 6566 |
| |
Press release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via Globenewswire


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