Glenmark gets CDSCO panel nod to market Remogliflozin, Teneligliptin, Metformin FDC drug

New Delhi: Granting permission for a local Phase III clinical trial and bioequivalence study waver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharma major Glenmark Pharma for manufacturing and marketing of an anti-diabetic Fixed Dose Combination (FDC) drug comprising of Remogliflozin etabonate 100mg, Teneligliptin 10mg and Metformin hydrochloride IP 500mg/1000mg.

However, the approval comes with a condition that the company should conduct a Phase IV Clinical Trial (CT) study in a significant number of patients. The committee also instructed the company to submit a Phase IV CT protocol within three months after receiving approval.

This came after the drug-maker Glenmark Pharmaceuticals presented their proposal before the committee for the anti-diabetic fixed dose drug combination drug comprising of Remogliflozin etabonate 100mg, Teneligliptin 10mg and Metformin hydrochloride IP 500mg/1000mg along with a request for Phase III CT and bioequivalence (BE) waiver (based on BCS classification).

The firm presented the result of Clinical study conducted with FDC of Remogliflozin 100mg + Teneligliptin 10mg when administered along with Metformin in Indian patients with type 2 diabetes mellitus.

Remogliflozin Etabonate is an orally available prodrug of remogliflozin, a benzylpyrazole glucoside-based inhibitor of renal sodium-glucose co-transporter subtype 2 (SGLT2) with antihyperglycemic activity. Upon administration and absorption, the inactive prodrug is converted to its active form remogliflozin and acts selectively on the sodium-glucose co-transporter subtype 2 (SGLT2).

Earlier the Medical Dialogues Team had reported that drugmaker, Glenmark Pharmaceuticals Limited, had launched a fixed dose combination (FDC) of its novel, patent protected and globally researched Sodium Glucose Co-Transporter Inhibitor (SGLT2i) - Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – Vildagliptin, in India.

Teneligliptin is a long-acting, orally bioavailable, pyrrolidine-based inhibitor of dipeptidyl peptidase 4 (DPP-4), with hypoglycemic activity.

Metformin is a popular antihyperglycemic agent that belongs to the biguanide class of drugs. It decreases blood glucose levels by decreasing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is the drug of choice for obese type II diabetes patients.

Now, at the 80th SEC meeting for Endocrinology & Metabolism held on 26.10.2021 at CDSCO, the committee extensively evaluated the drug major Glenmark's proposal for the anti-diabetic fixed-dose drug combination Remogliflozin etabonate 100mg, Teneligliptin 10mg and Metformin hydrochloride IP 500mg/1000mg tablet along with its request for Phase III CT and bioequivalence (BE) waiver.

After detailed deliberation, the SEC recommended the grant of permission to manufacture and market the subject FDC along with the condition of conducting a Phase IV CT study in a significant number of patients.

In addition, the committee also directed that the firm submit a Phase IV CT protocol within three months of the date of approval.