Glenmark gets CDSCO panel marketing nod to Remogliflozin, Teneligliptin FDC
New Delhi: In a major rejoice to Mumbai-based Glenmark Pharmaceuticals Limited, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod for marketing antidiabetic Fixed Dose Combination (FDC) drug Remogliflozin Etabonate plus Teneligliptin Hydrobromide Hydrate IP Eq. to Teneligliptin.
This came after Glenmark Pharmaceuticals presented the phase III clinical trial report before the committee in accordance with the SEC's prior recommendation dated 15.10.2020.
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 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.
With this approval, Glenmark became the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin with India being the first country to get access to this innovative drug. Glenmark subsequently launched Remogliflozin in India under the brand names 'Remo' and 'Remozen'.
Teneligliptin is an oral dipeptidyl peptidase 4 inhibitor indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise.
The FDC of the above mentioned two anti diabetic drugs, Remogliflozin Etabonate and Teneligliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus, to improve glycaemic control when metformin and one of the mono-components of the FDC of Remogliflozin Etabonate and Teneligliptin do not provide adequate glycaemic control.
Last year at the 63rd SEC meeting for Endocrinology & Metabolism, dated 23.01.2020, the firm presented their protocols for BA study and phase-III clinical trial.
The committee then suggested that authorization be granted to perform the proposed BA investigation and the proposed clinical trial research under specific conditions. The protocol for a phase III clinical study was authorised by the committee under the following conditions:
1) The rescue criteria should be revised to include fasting blood glucose (FBG) at 6 weeks should be 240 instead of 270.
2) There should be appropriate withdrawal criteria
In addition to this, the firm was directed that the trial should be initiated only after completion of the Bioavailability (BA) study and the result should be presented before the committee.
At the next SEC meeting for Endocrinology & Metabolism dated15.10.2020, the firm requested an amendment to the Phase III trial protocol. However, in this regards, the Committee noted that the firm initiated the Phase III trial without submitting the BA study report which was not in accordance with the conditions of the clinical trial permission issued by CDSCO for which CDSCO may take appropriate action. In respect to this, the committee at its 70th SEC meeting for Endocrinology & Metabolism, held on15.10.2020, rejected any amendment in the Phase III clinical trial protocol.
Now, proceeding further, at 87th SEC meeting for Endocrinology & Metabolism held on 15.06.2021 & 16.06.2021 at CDSCO, Glenmark Pharmaceuticals presented the Phase III CT report before the committee.
After detailed deliberation, the committee recommended for grant of permission for manufacturing and marketing the proposed FDC, Remogliflozin Etabonate plus Teneligliptin Hydrobromide Hydrate IP Eq. to Teneligliptin (100mg + 10mg) Film coated tablet.