Sanofi gets marketing approval for its diabetes drug Soliqua in India

Sanofi India has received marketing authorisation for its diabetes drug Soliqua (in pre-filled pen) from the Central Drugs Standard Control Organization (CDSCO). Soliqua is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes who are insufficiently controlled on oral or injectable therapies. It comes in once daily dosing of pre-filled pens in fixed-ratio combination (10-40 and 30-60) of insulin glargine and lixisenatide.

Cyrus Aibara, Head – Diabetes Business Unit, Sanofi (India) said, “With approximately 74 million Indians* (between the ages of 20-79 years) living with diabetes, healthcare professionals need more treatment options to customize diabetes care for them. Soliqua is the latest addition to our comprehensive diabetes portfolio (OADs and insulins) indicated for people with obesity who are living with insufficiently controlled diabetes. It will allow physicians to provide more tailored solutions for better diabetes management.”

Dr. Shalini Menon, Country Medical Lead, Sanofi (India) said,“Concerns about hypoglycemia and weight gain are known barriers when advancing diabetes treatments, more so when intensifying to a complex insulin regime. The global Solimix study** that included Indian patients, demonstrated that once daily Soliqua™ provides with weight benefit and less hypoglycaemia when compared with twice daily premixed insulin – thereby becoming a valuable option for endocrinologists.”

Soliqua (10-40 and 30-60 prefilled pens) is a once-daily injectable combination drug containing insulin glargine 100 Units/ml, which is a long-acting basal insulin and lixisenatide, a GLP-1 receptor agonist