Glenmark introduces remogliflozin, vildagliptin, metformin FDC for Type 2 Diabetes first time in the world

October 26, 2021 0 By Team FM

Mumbai-based drumaker Glenmark Pharmaceuticals has introduced a three drug fixed dose combination comprising remogliflozin etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – vildagliptin, with metformin (first-line treatment for diabetes), for the first company in the world. The company received approval from the Drug Controller General of India for manufacturing and marketing this fixed dose combination in September. 

The FDC– remogliflozin (100 mg), vildagliptin (50 mg) and metformin (500/ 1000 mg), which will be marketed under two brand names Remo MV and Remozen MV, is an innovative, patent-protected sodium glucose co-transporter-2 (SGLT2) inhibitor indicated for the treatment of Type 2 diabetes in adults, according to a company statement.  

With this launch, the company aims to improve patient access to SGLT2 inhibitors and DPP4 inhibitors which have proven benefits in the effective management of diabetes with added advantage of patient compliance, the statement added. The brands  are priced at Rs. 16.5 per tab, Rs. 33 respectively for per day dose, which is 53 percent lower than the other available SGLT2 and DPP4 combination brands administered along with metformin, in India. 

The company said that it is the only triple drug FDC considered rational for approval by the US FDA and in chronic diseases like Type 2 diabetes, patients are required to consume multiple anti-diabetic drugs for prolonged periods of time. Moreover, in India, patients have to bear the drug cost on their own and so the price of the drug becomes a major factor that impacts treatment adherence. While the average daily cost of therapy of existing brands in the same drug category (when clubbed together for price comparison) is around Rs. 75, Glenmark’s FDC to be taken twice daily costs only Rs.33.00 as the per day cost. This combination has been approved for adults aged 18 years and older with Type 2 diabetes to improve glycemic control when metformin and one of the mono-components of fixed dose combination do not provide adequate glycemic control, or when already being treated with separate doses of remogliflozin, vildagliptin and metformin.