Diabetes Treatment: CDSCO expert panel marketing authorization Nod to Glenmark's SGLT2 Inhibitor Remogliflozin etabonate
New Delhi: Mumbai-based Glenmark Pharmaceuticals Limited recently received the permission from the IND Committee of the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Remogliflozin etabonate(RE) tablets of 100mg strength. The product is indicated for the treatment of Type 2 Diabetes Mellitus (T2DM) as monotherapy and in addition to the existing anti-diabetic therapies.
The decision to this effect was taken up in the recent committee meeting held on 15th March 2019. The IND committee is headed by Dr Balram Bharagava, Director General ICMR.
The decision was given after the company submitted the results of statistical analysis of data after completion of 612 subjects of Phase III clinical study along with Pharmacokinetic study reports and requested for permission to manufacture and market the product in the country.
As per the proposal submitted, SGLT2 inhibitors are novel anti-diabetic drugs that help achieve glycemic control by acting on the SGLT2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine.
Prior to this, Glenmark had conducted various clinical trials for the product. Remogliflozin has been evaluated in 26 clinical studies (phases I, II and III). These studies provide information about the safety, efficacy, pharmacokinetics, pharmacodynamics, drug interaction and evaluation in special populations of Remogliflozin etabonate.
The committee after going through the clincial trial summary observed that the results of phase III clinical trial in Indian subjects with type 2 diabetes, confirm the efficacy and safety of Remogliflozin 100 mg and Remogliflozin 250 mg and non-inferiority with dapagliflozin 10 mg.
Based on all the efficacy and safety data, Remogliflozin etabonate is expected to be an important, effective and safe SGLT2 inhibitor for use in Indian subjects with type 2 Diabetes Mellitus.
In light of the recommendation of the IND committee meeting dated 03.12.2018, the firm presented their proposal along with results of the Phase III clinical trial data of first 612 subjects. The committee noted that in the Phase III clinical trial results, there is no much variation in terms of efficacy between Remogliflozin etabonate tablets 100 mg and 250 mg. After detailed deliberation, based on detailed non-clinical and clinical data (Phase I,II,III) generated, the committee recommended for grant of permission to manufacture and market Remogliflozin etabonate tablets of 100mg strength for the treatment of Type 2 Diabetes Mellitus (T2DM) as monotherapy and in addition to the existing anti-diabetic therapies subject to the following conditions:-
- The firm should submit protocol for active Post Marketing Surveillance of the drug to CDSCO before launching the product in the market.
- Proposed Package Insert, Label, Carton to be adopted should be got approved from CDSCO as per the requirements of the Rules.