Sanofi: SuliquaTM Approved in the European Union for the Treatment of Adults with Type 2 Diabetes
(Thomson Reuters ONE) -
Suliqua(TM) Approved in the European Union
for the Treatment of Adults with Type 2 Diabetes
Paris, France - January 18th , 2017 - Sanofi announced today that the European
Commission has granted marketing authorization in Europe for Suliqua(TM), the
once-daily titratable 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. Suliqua is authorized for use in combination with
metformin 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.(1)
"Suliqua is an innovative new combination therapy that has the potential to
address significant unmet needs for people living with type 2 diabetes in
Europe," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "The approval
of Suliqua represents the successful culmination of a concerted effort by Sanofi
scientists to bring two injectable treatments together in a single and precisely
titratable dose. Sanofi has a long history of elevating care for people with
diabetes, and we believe Suliqua will make it easier for patients with
inadequately controlled diabetes to reach their treatment goals."
The decision to grant marketing authorization in Europe for Suliqua was 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. Suliqua
demonstrated statistically superior blood sugar (HbA(1c)) reduction versus
lixisenatide (-0.8%, p<0.0001) and insulin glargine 100 Units/mL (-0.3%,
p<0.0001) in LixiLan-O, and versus insulin glargine 100 Units/mL (-0.5%,
p<0.0001) in LixiLan-L.(2,3)
Suliqua will be delivered in two pre-filled SoloSTAR(®) pens, providing
different dosing options that may help answer individual market and patient
insulin needs. The differentiation between the pen strengths is based on the
dose range and ratios of each pen. The 10-40 SoloSTAR pre-filled pen will
deliver 10 to 40 dose steps of insulin glargine 100 Units/mL 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 100 Units/mL in combination with
10 to 20 micrograms of lixisenatide.(1)
"We welcome the addition of Suliqua in the EU to help address the needs of
people living with type 2 diabetes who are currently not reaching their blood
sugar targets," said Javier Ampudia Blasco, Specialist of Endocrinology and
Nutrition at the Clinic University Hospital Valencia and Associate Professor of
Medicine at the Medicine Faculty of Valencia in Spain. "It is important to
achieve glycemic control without increasing the risk of hypoglycemic events or
additional weight gain when oral agents or basal insulin are no longer
sufficient. The simple administration of this combination product of insulin and
a glucagon-like peptide-1 receptor agonist in a single daily injection may help
to reduce the daily complexity of diabetes management and improve efficacy for
people with type 2 diabetes compared with its components. Suliqua is easy to use
with dose adjustments based only in the fasting glucose values."
Marketing authorization in Europe for Suliqua is applicable to the 28 member
states of the European Union, as well as Iceland, Liechtenstein and Norway, and
follows the November 2016 positive opinion issued by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA). The
product was approved by the U.S. Food and Drug Administration (FDA) in November
2016, as Soliqua(TM) 100/33, and has been available in the U.S. since January
4, 2017. Launches in individual EU countries are anticipated from Q2 2017
onward.
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).
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", "looks forward" 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, 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
1. Suliqua(TM) EU Summary of Product Characteristics, 2017.
2. Rosenstock J, et al. Diabetes Care. 2016, DOI: 10.2337/dc16-0917.
3. Aroda VR, et al. Diabetes Care. 2016, DOI: 10.2337/dc16-1495.
Press release (PDF):
http://hugin.info/152918/R/2071694/778538.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: 17.01.2017 - 19:20 Uhr
Sprache: Deutsch
News-ID 518158
Anzahl Zeichen: 9534
contact information:
Town:
PARIS
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 307 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Sanofi: SuliquaTM Approved in the European Union for the Treatment of Adults with Type 2 Diabetes"
steht unter der journalistisch-redaktionellen Verantwortung von
Sanofi (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
