Glenmark launches Remogliflozin, Vildagliptin, Metformin FDC at Rs 16.50 per tablet

Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, today announced that the company has launched a fixed dose combination (FDC) of its novel, patent protected, globally researched Sodium Glucose Co-Transporter Inhibitor (SGLT2i) - Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – Vildagliptin, with Metformin (first-line medication for the treatment of type 2 diabetes).

This fixed drug combination is indicated for the management of Type 2 diabetes. The combination contains Remogliflozin (100 mg) + Vildagliptin (50 mg) + Metformin (500/1000 mg) in a fixed dose and must be taken twice daily to improve glycemic control in patients. Glenmark has launched the same under two brand names Remo MV and Remozen MV.

Glenmark is the first company in the world to launch Remogliflozin + Vildagliptin + Metformin fixed dose combination (FDC) and India is the first country to get access to this FDC drug. Glenmark received approval from the DCGI (the drug approval authority in India) for manufacturing and marketing this fixed dose combination in late September 2021.

Globally, SGLT2 inhibitors & DPP4 inhibitors are emerging as the preferred treatment option for the management of Type 2 diabetes. 

Glenmark's FDC of Remogliflozin + Vildagliptin + Metformin tackles most of the pathophysiology in Type 2 Diabetes that makes it an appealing fixed dose combination in managing uncontrolled Type 2 Diabetes. Mono components of the FDC are recommended by AACE guideline for early use in the hierarchy of Anti diabetic medications for management of Type 2 diabetes. Further, FDC of SGLT2i + DPP4i + Metformin is currently first & only triple drug FDC considered rational for approval by US FDA.

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 Remogliflozin + Vildagiptin + Metformin combination has been launched at a breakthrough price of Rs. 16.50 per tablet, to be taken twice daily; which amounts to Rs.33.00 as the per day cost of therapy. This cost is atleast 53% lower than the other available SGLT2 & DPP4 combination drugs administered along with Metformin, in India .

Glenmark's Remogliflozin + Vildagliptin + Metformin combination will significantly improve access and bring a world class and well researched combination product at an affordable price to patients in India. This combination has been approved by the DCGI, the drug regulator in India 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.

"Globally, SGLT2i + DPP4i + Metformin FDCs are emerging as a preferred treatment for management of type2 diabetes. Diabetes is a key focus area for Glenmark and we have been at the forefront in providing access to the latest treatment options to diabetes patients in India. We are proud to introduce this innovative fixed dose combination, which is cutting-edge, extensively researched, at an affordable cost and will significantly improve patient compliance and provide glycemic & extra glycemic benefits to patients with uncontrolled Type 2 diabetes, in India" said Mr. Alok Malik, Group Vice President & Business Head, India Formulations.

In 2015, Glenmark revolutionized the diabetes market by launching its DPP4 inhibitor – Teneligliptin at a price that was approximately 55% lower than the other DPP4 inhibitors available in India at that time. Glenmark launched its globally researched, innovator molecule Remogliflozin in 2019, at a price around 55% lesser than other SGLT2 inhibitors available in the Indian market at that time. In 2020, Glenmark became the first company in the world to launch Remogliflozin (100 mg) + Vildagliptin (50 mg) Fixed Dose Combination (FDC).

According to the International Diabetes Federation (IDF), the prevalence of diabetes in India is 8.9% with around 77 million adults living with diabetes as of 2019 .

Read also: Glenmark gets CDSCO panel nod to market Remogliflozin, Vildagliptin, Metformin FDC drug