Toujeo® Receives Positive Opinion from the European Regulatory Authorities
(Thomson Reuters ONE) -
Toujeo(®) Receives Positive Opinion
from the European Regulatory Authorities
Paris, France - February 27, 2015 - Sanofi announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has issued a positive opinion recommending the approval of Toujeo(®)
(insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal
insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has
demonstrated a more stable and a prolonged glycemic control that lasts beyond
24 hours compared with Lantus(®) (insulin glargine [rDNA origin] injection, 100
U/mL) with low within-individual, within-day blood sugar variability.(1-3)
"Today's CHMP opinion is another step forward to make Toujeo available to people
living with diabetes who are currently not at their glycemic target, or are
about to start insulin therapy," said Pierre Chancel, Senior Vice President,
Global Diabetes, Sanofi. "We are confident that we can soon add this new
treatment option to our portfolio to help patients reach their blood sugar
goals."
The CHMP positive opinion of Toujeo is based on results from the EDITION
clinical trial program, a worldwide and extensive series of Phase III studies
evaluating the efficacy and safety of Toujeo compared to Lantus in more than
3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their
current therapy.(4-9) Toujeo demonstrated effective blood sugar control, with a
favorable safety profile. Toujeo significantly lowered hypoglycemic (low blood
sugar) risk in people with type 2 diabetes both at any time of the day and
night-time compared with Lantus.(10)
The European Commission (EC) is expected to make a final decision on granting
marketing authorization for Toujeo in the EU in the coming months. Toujeo was
approved by the U.S. Food and Drug Administration and is under review by other
regulatory authorities around the world.
Once approved, Toujeo will be available in the Toujeo SoloSTAR(®), a disposable
prefilled pen which contains 450 insulin units (IU), and it has a maximum single
injection dose of 80 IU.
About Toujeo
Despite basal insulin being a cornerstone treatment for diabetes for decades,
significant unmet medical needs remain a reality, with approximately half of
patients on treatment not reaching their blood sugar level targets.(11-16) In
addition, optimal insulin dose is often not reached during initiation or
maintenance phase. Toujeo is a next-generation, once-daily basal insulin based
on a broadly-used molecule (insulin glargine) with a well-established benefit-
risk profile.(17) Its compact subcutaneous depot leads to more stable and more
prolonged pharmacokinetic/pharmacodynamic (PK/PD) profiles. (1-3)
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
the field of healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets, animal health
and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
References
1. Steinstraesser A, Schmidt R, Bergmann K, et al. Diabetes, Obesity and
Metabolism. 2014;16(9):873-6, DOI: 10.1111/dom.12283.
2. Becker RHA, Dahmen R, Bergmann K, et al. Diabetes Care. 2014:epub ahead
of print, DOI: 10.2337/dc14-0006.
3. Shiramoto M, Eto T, Irie S, et al. Diabetes, Obesity and Metabolism.
2014:epub ahead of print, DOI: 10.1111/dom.12415.
4. Riddle MC, Bolli GB, Ziemen M, et al. Diabetes Care.
2014;37(10):2755-62, DOI: 10.2337/dc14-0991.
5. Yki-Järvinen H, Bergenstal R, Ziemen M, et al. Diabetes Care.
2014;37(12):3235-43, DOI: 10.2337/dc14-0990.
6. Bolli GB, Riddle MC, Bergenstal RM, et al. Diabetes, Obesity and
Metabolism. 2015:epub ahead of print, DOI: 10.1111/dom.12438.
7. Home P, Bergenstal R, Riddle M, et al. 50th Annual Meeting of the
European Association for the Study of Diabetes (EASD)2014. Oral presentation
abstract #148.
8. Matsuhisa M, Koyama M, Cheng X, et al. 50th Annual Meeting of the
European Association for the Study of Diabetes (EASD)2014. Poster abstract
#975.
9. Terauchi Y, Koyama M, Cheng X, et al. 50th Annual Meeting of the
European Association for the Study of Diabetes (EASD)2014. Poster abstract
#976.
10. Ritzel R, Roussel R, Bolli G, et al. 50th Annual Meeting of the European
Association for the Study of Diabetes (EASD)2014. Poster abstract #963.
11. Banegas JR, López-García E, Dallongeville J, et al. Eur Heart J.
2011;32(17):2143-52, DOI: 10.1093/eurheartj/ehr080.
12. Stark Casagrande S, Fradkin JE, Saydah SH, et al. Diabetes Care.
2013;36(8):2271-9, DOI: 10.2337/dc12-2258.
13. Chan JCN, Gagliardino JJ, Baik SH, et al. Diabetes Care.
2009;32(2):227-33, DOI: 10.2337/dc08-0435.
14. Choi YJ, Kim HC, Kim HM, et al. Diabetes Care. 2009;32(11):2016-20, DOI:
10.2337/dc08-2228.
15. Steinberg BA, Bhatt DL, Mehta S, et al. American Heart
Journal.156(4):719-27, DOI: 10.1016/j.ahj.2008.05.020.
16. Vouri SM, Shaw RF, Waterbury NV, et al. Journal of managed care pharmacy
: JMCP. 2011;17(4):304-12, DOI, http://www.ncbi.nlm.nih.gov/pubmed/21534641
17. Gerstein HC, Bosch J, Dagenais GR, et al. The New England journal of
medicine. 2012;367(4):319-28, DOI: 10.1056/NEJMoa1203858.
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 labeling 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, 2013.
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
Jack Cox Sébastien Martel
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
Tilmann Kiessling
Mobile: +(49) 17 26 15 92 91
tilmann.kiessling(at)sanofi.com
Link to PDF English:
http://hugin.info/152918/R/1897975/673928.pdf
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Unternehmensinformation / Kurzprofil:
Datum: 27.02.2015 - 13:16 Uhr
Sprache: Deutsch
News-ID 374906
Anzahl Zeichen: 10660
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