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Sanofi Gets Approval to Market its Med Device in India

Sanofi Gets Approval to Market its Med Device in India

Sanofi India has received marketing approval from India’s Central Drugs Standard Control Organization (CDSCO) for its diabetes drug Soliqua (in pre-filled pen). Soliqua is indicated as an adjunct treatment to improve glycemic control through diet and exercise in adults with obesity and type 2 diabetes who are inadequately controlled on oral or injectable therapies.

Soliqua is the latest addition to Sanofi’s  diabetes portfolio of oral antidiabetic drugs and insulins.

Soliqua Pen

Soliqua comes in once-daily pre-filled pens with fixed-ratio combinations of 10 units of insulin glargine and 40 mcg of lixisenatide (10-40) or 30 units of insulin glargine and 60 mcg of lixisenatide (30-60). Insulin glargine is a long-acting basal insulin while lixisenatide is a GLP-1 receptor agonist.

According to Cyrus Aibara, Head of Sanofi’s Diabetes Business Unit in India, this medication allows physicians to provide more customized solutions for improved diabetes management in obese patients with uncontrolled diabetes.

Dr. Shalini Menon, Country Medical Lead at Sanofi India, highlighted that concerns about hypoglycemia and weight gain are known barriers when intensifying diabetes treatments, especially with complex insulin regimens. The global SoliMix Study, which included Indian patients, demonstrated that once-daily Soliqua provides a weight benefit and less hypoglycemia compared to twice-daily premixed insulin, making it a valuable option for endocrinologists.

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