Glenmark Pharmaceuticals Ltd. announced it has received regulatory approval to market a combination of a novel drug, Remogliflozinc, and Metformin film-coated tablets in India.
Remogliflozin is an innovative, patent-protected sodium-glucose co-transporter-2 (SGLT2) inhibitor indicated in the treatment of Type 2 diabetes in adults
Glenmark will commercialize the product under the brand names “Remo-M” and “Remozen-M.”
“This approval for the combination of Remogliflozin and Metformin will only help us get closer to our goal of providing an effective, high-quality and world-class treatment option and improving access to SGLT2 inhibitors for patients in India,” said Sujesh Vasudevan, president, India formulations, Middle East and Africa at Glenmark Pharmaceuticals.
Earlier this year, Glenmark received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin.
With this approval, Glenmark has become the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin –with India being the first country to get access to this innovative drug, according to the company press release.
The approved dosage strengths are 100 mg of Remogliflozin combined with either 500 mg or 1,000 mg of Metformin.
This combination is indicated as an adjunct to diet and exercise to improve glycemic control in Type-2 diabetes mellitus patients (for full indication, it is advisable to refer the package insert).
The company had launched Remogliflozin as a mono-therapy, at a breakthrough price which is over 50% lower than the existing SGLT2 inhibitors available in India.
Prior to the launch of Remogliflozin, the average per day therapy cost of SGLT2 inhibitors in India was about Rs. 55.