Glenmark Pharmaceuticals on April 30 launched a novel and patented anti-diabetes drug belonging to the class of sodium glucose co-transporter-2 (SGLT2) inhibitor, which is said to be 50-60 percent cheaper than the existing medications of same class in the market.
The drug, generically called as Remogliflozin etabonate, is used in the treatment of type-2 diabetes mellitus in adults and was approved by Indian drug regulator CDSCO in March this year. India is the first country where the drug will be sold.
According to data from IQVIA, India's diabetes market is estimated at Rs 11,413 crore for the year ended March 2019. The market size of SGLT2 inhibitors is estimated at Rs. 574 crore in the same period.
The exact price of Remogliflozin isn't yet known.
At present three versions of SGLT2 inhibitors are sold in India belonging to British drug maker Astrazeneca's dapagliflozin (Farxiga), US-based Janssen Pharmaceuticals canagliflozin (Invokana) and Germany-based Boehringer Ingelheim's empagliflozin (Jardiance). Their cost range anywhere between Rs 450 to Rs 550 per 10 tablets.
Glenmark said it will commercialise Remogliflozin in India under brand names Remo and Remozen.
SGLT2 inhibitors are third generation anti-diabetic drugs that help achieve glycemic control by acting on the SGLT2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine.
SGLT2 drugs provide glycemic control, induce weight loss and reduce cardiovascular risks.
Glenmark received regulatory approval for Remogliflozin 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.
Remogliflozin, the latest drug in SGLT2 inhibitors' class to get regulatory approval in the world, has been studied in 26 clinical trials globally, covering around 2,500 people from various ethnicities.
Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical and later developed by GlaxoSmithKline and Glenmark collaborator BHV Pharma, a wholly-owned subsidiary of Avolynt.
Glenmark secured certain rights to Remogliflozin through a licensing collaboration agreement with BHV Pharma, and conducted the Phase-3 clinical trial.
"Globally, SGLT2 inhibitors are emerging as a preferred treatment for management of type-2 diabetes and Glenmark is proud to introduce a novel molecule in this class, which is cutting-edge and researched extensively. Diabetes is a key area of focus for Glenmark and with the launch of Remogliflozin, the company aims to improve access to SGLT2 inhibitors by providing an effective, high quality and world-class treatment option to patients in India," said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals.
The American Diabetes Association and the European Association for the Study of Diabetes have recommended use of SGLT2 inhibitors as an alternative first line treatment to Metformin or as an adjunctive treatment in the management of type-2 diabetes mellitus.
SGLT2 inhibitors are particularly recommended for use in patients that have certain established cardiovascular diseases.
India is estimated to have around 72 million adults living with diabetes, according to the International Diabetes Federation’s Diabetes Atlas 2017.
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