Sanofi Receives CHMP Recommendation for Approval of Insulin Lispro Biosimilar
May 19 2017 - 6:10AM
Sanofi Receives CHMP Recommendation
for Approval of Insulin Lispro Biosimilar
- Positive opinion based on a clinical
development program involving over 1,000 people with type 1 or
type 2 diabetes -
Paris, France - May 19, 2017 - 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 Insulin lispro
Sanofi® (insulin lispro 100 Units/mL). CHMP recommended the use of
Insulin lispro Sanofi® to treat adults and children who have
diabetes and need insulin to keep their blood sugar level
controlled, including those patients whose diabetes has just been
diagnosed. This positive opinion is the company's first major
regulatory milestone for a biosimilar diabetes treatment.
"We welcome the CHMP positive opinion for
Insulin lispro Sanofi® and look forward to the final decision of
the European Commission (EC)," said Jorge Insuasty MD, Senior Vice
President, Global Head of Development, Sanofi. "Our development of
this investigational biosimilar product reflects Sanofi's expertise
and long-term heritage in developing and manufacturing high-quality
insulins for people with type 1 or type 2 diabetes and their
physicians."
The recommendation is based on a clinical
development program involving over 1,000 adults with type 1 or type
2 diabetes. This program comprised a pharmacokinetic /
pharmacodynamic (PK/PD) Phase 1 study to evaluate the product's
similarity in exposure and activity compared to insulin lispro 100
Units/mL as currently approved in the U.S. and EU1, two
multi-center Phase 3a clinical trials (SORELLA 12 and SORELLA 2)
evaluating its safety and efficacy compared to insulin lispro 100
Units/mL as currently approved in the U.S. and EU in adults with
type 1 or type 2 diabetes, and a safety study in insulin pumps in
adults with type 1 diabetes.
"Insulin lispro is an important and widely-used
treatment for people with diabetes who require rapid control of
their blood sugar at mealtime," said Peter Guenter, Executive Vice
President and General Manager, Diabetes & Cardiovascular,
Sanofi. "By broadening our portfolio of quality insulin options, we
acknowledge our commitment to expand the affordability and
sustainability of insulin treatments."
The European Commission is expected to make a
final decision on marketing authorization for Insulin lispro
Sanofi® in the coming months.
About Insulin lispro Sanofi® (insulin lispro
100 Units/mL)Insulin lispro Sanofi® is a biosimilar of insulin
lispro, a rapid-acting insulin analog, produced using recombinant
DNA technology and has the identical amino acid sequence as its
reference product. It is currently not approved by any regulatory
authority. It was submitted to the European Medicines Agency (EMA)
in September 2016.
About SanofiSanofi, 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).
References
- Kapitza C et al, Similar pharmacokinetics and pharmacodynamics
of rapid-acting insulin lispro products SAR342434 and US- and
EU-approved Humalog in subjects with type 1 diabetes. Diabetes Obes
Metab. 2017 May;19(5):622-627.
- Garg SK et al, Abstract #863 presented at European Association
for the Study of Diabetes (EASD) 52nd Annual Meeting, September
2016. Available via
http://www.easdvirtualmeeting.org/resources/similar-glucose-control-post-prandial-glucose-excursions-and-safety-in-people-with-type-1-diabetes-mellitus-on-mdi-using-sar342434-or-insulin-lispro-and-insulin-glargine-u100-sorella-1-study
[Accessed April 2017].
Forward-Looking StatementsThis 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
the product. 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 the product, 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 the product as well as their
decisions regarding labeling and other matters that could affect
the availability or commercial potential of the product, the
absence of guarantee that the product 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, 2016. 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
RelationsMai Tran Tel.: + (33) 1 53 77 46
46 mr@sanofi.com |
Investor RelationsGeorge GrofikTel.: +33 (0)1 53 77 45
45ir@sanofi.com |
Attachments:
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