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Glenmark Pharmaceuticals launches fixed-drug combination for management of type 2 diabetes

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Mumbai (Maharashtra) | October 26, 2021 11:16:55 AM IST
Glenmark Pharmaceuticals Limited (Glenmark), a research-led global pharmaceutical company has launched a fixed drug combination for the management of type 2 diabetes.

According to a statement issued by Glenmark Pharmaceuticals Limited, 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).

"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," said the statement.

With the launch of Remogliflozin-Vildagliptin-Metformin fixed-dose combination (FDC), Glenmark has become the first country in the world to do so and India becomes the first country to gain 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," said the statement.

Glenmark, in its release, said that SGLT2 inhibitors and DPP4 inhibitors are emerging as the preferred treatment option for the management of type 2 diabetes globally.

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 guidelines for early use in the hierarchy of Antidiabetic medications for the management of type 2 diabetes. Further, FDC of SGLT2i + DPP4i + Metformin is currently first and only triple-drug FDC considered rationale for approval by US FDA," said the statement.

Glenmark further informed that the cost of the drug will just be Rs 16.50 per tablet, to be taken twice daily as against Rs 75 as an average cost of existing brands.

The statement further said, "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."

"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 and extra glycemic benefits to patients with uncontrolled type 2 diabetes, in India," said the Group Vice President and Business Head, India Formulations, Alok Malik. (ANI)

 
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