Lyxumia® is First Diabetes Therapy of its Class Approved in Japan for use in Combination with Basal Insulin

Lyxumia® is First Diabetes Therapy of its Class Approved in Japan for use in 
Combination with Basal Insulin 
- 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: SANand 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 approvedin Japanfor use in 
combination with basal insulin, will bea valuable new treatmentoption 
formany of the country's 6 millionpluspeople living with type 2 
diabetes," said Pierre Chancel, Senior Vice-President, Global Diabetes at 
Sanofi."TheMHLWdecisionimmediately enablestheuse 
ofLyxumia,whichworks 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),([1],[2]) as 
diabetes progresses over time, patients treated with basal insulin may no 
longer stay at their HbA(1c) 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 HbA(1c) goals. 
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 from Japan.([3]) 
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 diabetes. 
About Sanofi 
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 (NYSE: SNY). 
References 
1. Aronoff et al. Glucose metabolism and regulation: Beyond insulin 
 and glucagon. Diabetes Spectrum 2004; 17(3): 183-190.
  2. 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.
  3. 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.

Corporate Media Relations, Marisol Péron, Tel.: +(33)-1-53-77-45-02,  
marisol.peron@sanofi.com; Investor Relations, Sébastien Martel, Tel.:  
+(33)-1-53-77-45-45,ir@sanofi.com; Global Diabetes Division Communications, 
Philip McNamara, Tel:  +(1)-908-981-5497, Mobile: 
+(1)908-210-4047,philip.mcnamara@sanofi.com

SOURCE: Sanofi Diabetes

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CO: Sanofi Diabetes

-0- Jun/28/2013 11:22 GMT


 
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