Sanofi Receives CHMP Recommendation for Approval of SuliquaTM in the EU
(Thomson Reuters ONE) -
Sanofi Receives CHMP Recommendation for Approval of Suliqua(TM) in the EU
Paris, France - November 11, 2016 - Sanofi announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion for the marketing authorization of
Suliqua(TM), the once-daily titratable fixed-ratio combination of basal insulin
glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. CHMP recommended
the use of Suliqua in combination with metformin for the treatment of adults
with type 2 diabetes mellitus to improve glycemic control when this has not been
provided by metformin alone or metformin combined with another oral glucose
lowering medicinal product or with basal insulin.
"We welcome the CHMP positive opinion for Suliqua and look forward to the final
decision of the European Commission (EC), as well as the upcoming U.S. Food and
Drug Administration decision," said Elias Zerhouni, M.D., President, Global R&D,
Sanofi. "Today's opinion brings us one step closer to delivering in Europe this
important and innovative treatment option, which combines two widely used and
complementary medicines into a single daily injection that we feel will benefit
people with type 2 diabetes who are struggling to keep their blood sugar levels
under control."
The CHMP positive opinion is based on data from two Phase 3 studies, LixiLan-O
and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes
worldwide to evaluate the efficacy and safety of the fixed-ratio combination
when used in patient populations insufficiently controlled after OADs and after
basal insulin therapy, respectively. Both studies met their primary
endpoints, demonstrating statistically superior HbA1c reduction versus
lixisenatide and insulin glargine 100 Units/mL in LixiLan-O,(1) and versus
insulin glargine 100 Units/mL in LixiLan-L.(2)
Suliqua is the brand name in Europe for the once-daily titratable fixed-ratio
combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist
lixisenatide. The European Commission is expected to make a final decision on
marketing authorization for Suliqua in the coming months. The fixed-ratio
combination is currently under review in a total of nine markets, including the
United States, where a U.S. Food and Drug Administration decision is anticipated
later this month.
Once approved, Suliqua will be available in the EU in two pre-filled SoloSTAR®
pens, providing different dosing options that will help answer individual market
and patient needs. The differentiation between the pen strengths is based on the
dose range of each pen. The 10-40 SoloSTAR pre-filled pen will deliver 10 to
40 dose steps of insulin glargine in combination with 5 to 20 micrograms of
lixisenatide. The 30-60 SoloSTAR pre-filled pen will deliver 30 to 60 dose steps
of insulin glargine in combination with 10 to 20 micrograms of lixisenatide.
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 Merial. 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 clinical development of and potential
marketing approvals for Suliqua. Forward-looking statements are generally
identified by the words "expects", "anticipates", "believes", "intends",
"estimates", "plans", "will be" 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 of Suliqua, 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
Suliqua as well as their decisions regarding labeling and other matters that
could affect the availability or commercial potential of Suliqua, the absence of
guarantee that Suliqua if approved will be commercially successful, risks
associated with intellectual property, future litigation, the future approval
and commercial success of therapeutic alternatives, 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.
Contacts:
Media Relations Investor Relations
Mai Tran George Grofik
Tel.: + (33) 1 53 77 46 46 Tel.: + (33) 1 53 77 45 45
mr(at)sanofi.com ir(at)sanofi.com
Global Diabetes Communications
Philip McNamara
Tel.: +1 908 938 0390
philipmcnamara(at)sanofi.com
References
1. Rosenstock J, et al. Diabetes Care. 2016, Online ahead of print, DOI:
10.2337/dc16-0917.
2. Aroda VR, et al. Diabetes Care. 2016, Online ahead of print, DOI:
10.2337/dc16-1495.
Press release (PDF):
http://hugin.info/152918/R/2056017/770056.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 11.11.2016 - 13:19 Uhr
Sprache: Deutsch
News-ID 506479
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