Glenmark Pharmaceuticals on Tuesday said it has launched a fixed-dose combination drug for the treatment of Type 2 diabetes in the country.
It has introduced a fixed-dose combination of Remogliflozin Etabonate and Vildagliptin in India for the management of Type 2 diabetes, the Mumbai-based company said in a statement.
The drug contains Remogliflozin (100 mg) and Vildagliptin (50 mg) in a fixed-dose and must be taken twice daily to improve glycemic control in patients, it added.
The company has launched the product under two brand names — Remo V and Remozen V — in the country. “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,” the drugmaker said.
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.
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. Continuing the legacy, 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).
Glenmark Pharmaceuticals Limited (Glenmark) is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It ranks among the world’s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa’s Generics Bulletin). The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry being featured in the index