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Sanofi : FDA Accepts Sanofi New Drug Application for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

FDA Accepts Sanofi New Drug Application for

Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

- FDA decision anticipated in August 2016 -

- Regulatory submission based on results from Phase 3 clinical trial program
in adults with type 2 diabetes -

Paris, France - February 22, 2016
Sanofiannounced today that the U.S. Food and Drug Administration (FDA) has
accepted the New Drug Application (NDA) for its investigational fixed-ratio
combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist
lixisenatide for the treatment of adults with type 2 diabetes.

Following the redemption of a Priority Review Voucher with the submission, an
FDA decision is anticipated in August 2016.

The FDA filing notification is an important milestone for Sanofi as we work to
broaden our diabetes portfolio,"
said Pascale Witz, Executive Vice President, Global Diabetes&Cardiovascular,
Sanofi. "Physicians may need to consider fasting and mealtime blood glucose
in their overall management of diabetes, and additional treatment options are
needed. We look forward to working with the FDA during the review process
with a view toward bringing this investigational medicine to adults with type
2 diabetes in the U.S."

This NDA submission is based on data from two Phase 3 studies, which enrolled
more than 1,900 patients worldwide to evaluate the safety and efficacy of the
fixed-ratio combination when used in patient populations insufficiently
controlled after oral antidiabetic agents (OADs) and after basal insulin
therapy, respectively. Both studies met their primary endpoints and will be
presented at a medical congress in 2016.

The safety and efficacy of the fixed-ratio combination have not been evaluated
by any regulatory authority, and the proprietary name is under consideration.
Preparations are on track for regulatory submission in the European Union in
March 2016. The investigational GLP-1 receptor agonist lixisenatide was
evaluated in patients with type 2 diabetes and is also currently under review
by the FDA. The NDA for lixisenatide was accepted in September 2015, and an
FDA decision is anticipated in July 2016.

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).

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 initiatives 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 |
| |
|Media Relations Sébastien Martel |
| Tel: + (33) 1 53 77 45 45 |
|Coralie Savin ir@sanofi.com |
|Tel: + (33) 1 53 77 46 46 |
|mr@sanofi.com |
| Global Diabetes Communications U.S. Diabetes Communications |
| |
|Philip McNamara Susan Brooks |
|Tel: +1 908 981 5497 Tel: +1 908 981 6566 |
|philip.mcnamara@sanofi.com susan.brooks@sanofi.com |
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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