Glenmark Pharmaceuticals, the Mumbai-headquartered Indian pharmaceutical major, on Tuesday launched its novel, patent-protected and globally-researched sodium glucose co-transporter-2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) in India. The drug used in the treatment of type-2 diabetes mellitus in adults has been priced at 55-60 per cent discount to the cost of available SGLT-2 medication in the market, according to the company spokesperson. Glenmark secured marketing and distribution rights to Remogliflozin through a licensing collaboration agreement with BHV Pharma and has conducted the Phase-3 clinical trial in India. Thereafter, it received the approval from the Indian drug controller.
Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical Co and was later developed by GlaxoSmithKline plc and Glenmark collaborator BHV Pharma, a wholly-owned subsidiary of Avolynt, Inc. which is based in North Carolina, USA.
"SGLT2 inhibitors are novel anti-diabetic drugs that help achieve glycemic control by acting on the SGLT-2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. SGLT-2 drugs provide glycemic control, induce weight loss and reduce cardiovascular risks," a release put out by the company says.
Doctors, however, are keen to get more details about the drug. Dr V Mohan, co-founder of Dr Mohan's Diabetes Specialities Centre says, "While we need more data about the molecule, especially on its efficacy and safety, in this class of compounds, currently we have three international products - Dapagliflozin, Canagliflozin and Empagliflozin- marketed by international companies. These have been in the market for many years. If this new drug is being launched at nearly half the cost and with good efficacy and safety, then it will be good for the patients." The SGLT 2 class of drugs, however, he says, are known to have multiple benefits beyond blood glucose control. For instance, these are known to help in weight loss, reducing blood pressure and are shown to have a good effect on the heart and kidneys.
Glenmark calls itself, "the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin and India, the first country to get access to this innovative drug. Glenmark will commercialise Remogliflozinin India under the brand names "Remo" and "Remozen".
Glenmark, the company's press release points out, 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. Remogliflozin, it says, is 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.