Glenmark Pharmaceuticals Limited on Tuesday said that it has launched a fixed-dose combination (FDC) drug for the management of Type 2 diabetes in India.

The company has launched a fixed-dose combination of its novel, patent-protected Sodium-Glucose Co-Transporter Inhibitor (SGLT2i) - Remogliflozin Etabonate and a 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 blend 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, the company said.

Glenmark has launched the FDC drug 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,” the company said in a statement.

DCGI nod

It has received approval from the DCGI (the drug approval authority in India) for manufacturing and marketing this fixed-dose combination in late September 2021.

The Indian drug regulator has approved the use of the combination drug 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,” it said.

With this launch, the company aims to improve patient access to SGLT2 inhibitors & DPP4 inhibitors, which have proven benefits in the effective management of diabetes with the added advantage of patient compliance

Priced at ₹16.50 per tablet, to be taken twice daily, which amounts to ₹33.00 as the per-day cost of therapy.

“Globally, SGLT2i + DPP4i + Metformin FDCs are emerging as a preferred treatment for management of Type 2 diabetes,” said Alok Malik, Group Vice President & Business Head, India Formulations.

“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,” added Malik.

According to the International Diabetes Federation (IDF), around 77 million adults were living with diabetes in India as of 2019 with the prevalence of diabetes in the country being 8.9 per cent.

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