Glenmark Pharmaceuticals is bringing to India Remogliflozin etabonate, a drug used to treat adults with Type 2 diabetes. The Mumbai-based pharma major expects the drug to be a “disrupter” in its segment, even as some diabetologists are calling for more safety- and efficacy-related data on the drug.
Remogliflozin is part of the SGLT2 (sodium glucose co-transporter-2) inhibitor family. “These are a new class of drugs and different molecules of this family have been in India for more than three years,” said Sujesh Vasudevan, President - India Formulations, Glenmark. These drugs are known to help patients additionally in terms of cardiovascular benefits and weight loss, he explained.
Glenmark did the phase III clinical trials for Remogliflozin in India after it received certain rights to it through a licensing collaboration with BHV Pharma.
Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical Co and subsequently developed by GlaxoSmithKline Plc and BHV Pharma, a wholly-owned subsidiary of Avolynt Inc. Glenmark said it was the first in the world to launch Remogliflozin and India was the first country to get access to this drug.
Category disruption
“The category is still in its infancy and doctors have sometimes found it difficult to prescribe these drugs on price considerations,” Vasudevan said. However, he expects Remogliflozin to do a Teneligliptin, another diabetes drug that had disrupted its category with its reduced price and safety profile.
Remogliflozin will be priced at ₹12.50 per tablet, Vasudevan told BusinessLine , about half that of others in its class. Countering concerns raised by some diabetologists that data on this drug is not sufficient, he said there is enough data generated, including from Indian patients.
Remogliflozin has been studied in 26 clinical trials globally, covering about 2,500 patients from various ethnicities. Key side-effects included urinary tract infections as the sugar was excreted, Vasudevan said, besides fungal infections.
Diabetologist Dr V Mohan said the three other molecules in this class have been around in India. There is long-term data on them, including follow-ups on their impact on the heart, kidneys etc, he added.
“Siblings of a family (of drugs) may not be the same,” he said, calling for more data on Remogliflozin. Cost is not the only factor, he said, adding that doctors would be encouraged to use it if they could generate data to show that the drug was safe.
Getting to know Remogliflozin
It is an SGLT2 inhibitor indicated in the treatment of type-2 diabetes mellitus in adults
SGLT2 inhibitors provide glycemic control, induce weight loss and reduce cardiovascular risks
Glenmark is the first in the world to launch Remogliflozin and India is the first country to get access to the innovative drug
Others in the family of drugs include Empagliflozin, Dapagliflozin and Canagliflozin