Glenmark Pharmaceuticals has launched a fixed-dose combination (FDC) of its novel, patent-protected Sodium Glucose Co-Transporter Inhibitor (SGLT2i) – Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – Vildagliptin, in India.
The fixed drug combination is indicated for the management of Type 2 diabetes. The combination will contain Remogliflozin (100 mg) + Vildagliptin (50 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 and Remozen V. “Glenmark is the first company in the world to launch Remogliflozin + Vildagliptin fixed-dose combination 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 Remogliflozin + Vildagliptin combination in late November 2020,” informs the company in a statement.
It further informs, “While the average daily cost of therapy of existing brands in the same drug category is Rs 78, Glenmark’s Remogliflozin-Vildagiptin combination has been launched at a breakthrough price of Rs 14 per tablet, to be taken twice daily; which amounts to Rs 28 as the per-day cost of therapy. This cost is 65 per cent lower than the other available SGLT2 & DPP4 combination drugs in the market.”
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 and Vildagliptin.
“We are glad to introduce this innovative fixed-dose combination, which is cutting-edge, extensively researched and at an affordable cost for patients in the country. Diabetes is a key area of focus for Glenmark and the launch of this product will enable us to improve access to diabetes treatment by providing an effective, high quality, world-class and affordable treatment option to patients in India,” said Alok Malik, Group Vice President & Business Head, India Formulations.