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Sanofi launches diabetes drugs, Lyxumia and Zemiglo in India

Our Bureau, Mumbai
Tuesday, July 19, 2016, 17:20 Hrs  [IST]

Sanofi-Synthelabo India Private Limited announced the launch of two drugs for type 2 diabetes patients in India: Lyxumia (lixisenatide) and Zemiglo (gemigliptin). Lyxumia is a once daily, non-insulin injectable drug and Zemiglo is a once daily, oral tablet.

As per the International Diabetes Federation Diabetes Atlas 2015, India is home to the second largest number of adults living with diabetes worldwide, after China, with 69.1 million patients and expected to rise to 1401 million in 2040. India is the largest contributor to South East Asia regional mortality, with 1 million deaths attributable to diabetes.

These statistics reveal how diabetes is fast gaining the status of a potential epidemic in India and establishes the need for treatment compliance and effective control through diet, exercise and drugs for long-term positive effects in disease management.

N Rajaram, country head & general Manager - pharmaceutical operations said, “The challenge people living with diabetes face today is to keep their glucose levels under control; nearly 50 per cent of people living with diabetes remain uncontrolled. Sanofi India is proud of its strong legacy in diabetes management.
We have a diversified portfolio of oral and insulin therapies, including Lantus and Amaryl that have been supporting people in diabetes management for over a decade. The launch of two additions to Sanofi India portfolio - Lyxumia and Zemiglo, is our step forward in developing new solutions for people with type 2 diabetes. It is also a testament to Sanofi India’s commitment to help to address the current treatment gaps in our country. We are excited to bring these molecules to India.”

Sanofi India’s integrated portfolio of marketed products provides treatment, monitoring and support at every stage of the diabetes journey. Lyxumia and Zemiglo are critical elements of this portfolio.

Dr Mubarak Naqvi, head - medical affairs, India & South Asia said, “The development and clinical use of Dipeptidyl Peptidase-4 (DPP-4) inhibitors and Glucagon-Like Peptide-1 (GLP-1) receptor agonists are relatively recent advancements in the management of type 2 diabetes. These class of drugs will help people living with diabetes reduce HbA1c and maintain their targets, with minimal chances of hypoglycemia. Lyxumia has demonstrated an added benefit of weight reduction in Type 2 diabetes patients. Lyxumia is a right fitment for adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin like Lantus, when these alone,  do not provide adequate glycemic control. It targets the meal-time increase in blood sugar and helps patients reach their treatment targets. In addition, Gliptins are increasingly being used for people with diabetes because of their low risk of hypoglycemia (low blood sugar), and overall safety and efficacy. Zemiglo, our gliptin has shown these benefits in Indian people living with diabetes.”

Lyxumia is currently approved in over 70 countries worldwide for the treatment of type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. It has been filed in the US for approvals. Zemiglo has been approved in South Korea in 2012 and already has over three years of clinical experience. It is now available in India.

Lyxumia and Zemilgo are prescription drugs and are to be taken only when prescribed by the doctor. Zemiglo belongs to the Dipeptidyl Peptidase-4 (DPP-4) inhibitor class of anti-diabetic drugs, also known as gliptins. It is a once a day, oral drug that helps to bring down the glucose levels. Being a gliptin, it ensures minimal chances of hypoglycemia (low blood sugar) and is weight neutral. (ie. it does not lead to weight gain or weight loss).

The dose is a single 50 mg tablet – the smallest size of gliptin, which is to be taken orally once daily and requires no dose adjustment in kidney disease. Zemiglo comes in a pack of 2 strips of 14 tablets each, priced at Rs. 42.70, per tablet. Lyxumia is a glucagon-like-peptide (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.

It is indicated for use either on top of basal insulin like Lantus and /or in combination with oral anti-diabetic medications. It needs to be administered once daily, within the hour prior to any meal of the day. It helps the body produce more insulin when blood glucose levels become too high, and also reduces the production of glucagon, which usually acts against insulin to increase glucose levels. Lyxumia has the potential benefits of low risk of hypoglycemia (low blood sugar) and weight reduction.

It is the 1st drug in its class with proven cardiovascular safety in ELIXA trial. Lyxumia comes in a pre-filled pen of either 10 mcg or 20 mcg, both priced at Rs. 4,114 per pen, which is simple and easy to inject.


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