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

New Delhi: 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, Vildagliptin, and Metformin.

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 Remogliflozin etabonate 100mg/100mg plus Vildagliptin 50mg/50mg plus Metformin Hydrochloride 500mg/1000mg tablet along with a request for Phase III CT and bioequivalence (BE) waiver (based on BCS classification).

In addition to this, the firm also presented the results of a clinical study conducted with FDC of Remogliflozin 100mg + Vildagliptin 50mg when administered along with Metformin in Indian patients with type 2 diabetes mellitus.

Remogliflozin Etabonate is an orally available prodrug of remogliflozin. It is a selective antagonist of the sodium-dependent glucose transporter 2 (SGLT2) located in the renal proximal tubules. It lowers glucose concentrations in type 2 diabetes by inhibiting renal glucose reabsorption. 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 in April 2019, Glenmark had received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated a good efficacy and safety profile in a head-to-head comparison against Dapagliflozin.

With this authorization, Glenmark became the first company in the world to market Remogliflozin, a novel SGLT2 inhibitor, with India being the first country to receive access to the medicine. Glenmark subsequently launched Remogliflozin in India under the brand names 'Remo' and 'Remozen'.

Glenmark is the first company in the world to launch a Remogliflozin + Vildagliptin fixed dose combination and India is the first country to get access to this FDC drug. 

Vildagliptin is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. By inhibiting DPP-4, vildagliptin prevents the degradation of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are incretin hormones that promote insulin secretion and regulate blood glucose levels. Elevated levels of GLP-1 and GIP consequently result in improved glycemic control.

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 78th SEC meeting for Endocrinology & Metabolism held on 24.08.2021 & 25.08.2021 at CDSCO, the committee extensively evaluated the drug major Glenmark's proposal for the anti-diabetic fixed-dose drug combination Remogliflozin etabonate 100mg/100mg plus Vildagliptin 50mg/50mg plus Metformin Hydrochloride 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.