- First once-daily prandial GLP-1 receptor agonist offering a new
treatment option for Japanese people living with type 2 diabetes -
PARIS, June 28, 2013 /CNW/ - Sanofi (EURONEXT : SAN and NYSE : SNY)
announced today that Japan's Ministry of Health, Labour and Welfare
(MHLW) has approved the manufacturing and distribution of Lyxumia® (lixisenatide) for the treatment of type 2 diabetes. Lyxumia, the first
once-daily prandial GLP-1 receptor agonist (RA), is also the first
GLP-1 RA approved in Japan for use in combination with basal insulin.
Lyxumia is indicated for patients with type 2 diabetes mellitus when
the following do not provide adequate glycemic control: diet and
exercise and sulfonylureas (with and without biguanides) or diet and
exercise and soluble prolonged-acting or intermediate-acting insulin
(with and without sulfonylureas).
"Lyxumia, as the first GLP-1 receptor agonist approved in Japan for use in combination with basal insulin, will be a valuable new treatment option for many of the country's 6 million plus people living with type 2 diabetes," said Pierre Chancel, Senior Vice-President, Global Diabetes at Sanofi. "The MHLW decision immediately enables the use of Lyxumia, which works in a way that complements basal insulin."
Although basal insulin treatment provides effective control of overall
glucose excursions by primarily targeting fasting plasma glucose (FPG),, as diabetes progresses over time, patients treated with basal insulin
may no longer stay at their HbA1c goals, despite good control of FPG. When this happens, adding a
medicine such as Lyxumia, which targets post-prandial glucose, may be
an effective strategy to further lower blood glucose levels and reach
MHLW approval in Japan is supported by the international GetGoal
program, which included a total of 11 clinical trials involving more
than 5,000 patients with type 2 diabetes. Among these trials is the
pivotal Phase III study GetGoal-L-Asia, which included 159 patients
Lyxumia is now approved in Mexico, the European Union, Australia and
Japan. The New Drug Application for lixisenatide in the United States
is currently being reviewed.
About Lyxumia® (lixisenatide)
Lyxumia® (lixisenatide) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA)
for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a
naturally-occurring peptide hormone that is released within minutes
after eating a meal. It is known to suppress glucagon secretion from
pancreatic alpha cells and stimulate glucose-dependent insulin
secretion by pancreatic beta cells.
Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL), http://www.zealandpharma.com, and is approved in Europe for the treatment of adults with type 2
diabetes mellitus to achieve glycemic control in combination with oral
glucose-lowering medicinal products and/or basal insulin when these,
together with diet and exercise, do not provide adequate glycemic
control. Lyxumia is also approved in Mexico and Australia for the
treatment of adults with type 2 diabetes. Lyxumia is the proprietary
name approved by the European Medicines Agency and other health
authorities for the GLP-1 RA lixisenatide. The proprietary name for
lixisenatide in the United States is under consideration.
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
innovative blood glucose monitoring systems. Sanofi markets both
injectable and oral medications for people with type 1 or type 2
Sanofi, an integrated 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
Aronoff et al. Glucose metabolism and regulation: Beyond insulin and
glucagon. Diabetes Spectrum 2004; 17(3): 183-190.
Riddle et al. Contributions of basal and postprandial hyperglycemia over
a wide range of A1c levels before and after treatment intensification
in type 2 diabetes. Diabetes Care 2011; 34(12): 2508-2514.
Seino Y et al. Randomized, double-blind, placebo-controlled trial of the
once-daily GLP-1 receptor agonist lixisenatide in Asian patients with
type 2 diabetes insufficiently controlled on basal insulin with or
without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab 2012; 14(10): 910-977.
SOURCE: Sanofi Diabetes
For further information:
Corporate Media Relations, Marisol Péron, Tel.: +(33)-1-53-77-45-02, firstname.lastname@example.org; Investor Relations, Sébastien Martel, Tel.: +(33)-1-53-77-45-45, email@example.com; Global Diabetes Division Communications, Philip McNamara, Tel: +(1)-908-981-5497, Mobile: +(1)908-210-4047, firstname.lastname@example.org