New Delhi: Granting the Phase III clinical trial study waiver for the proposed antidiabetic fixed-dose combination (FDC), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to pharma major Synokem Pharma for manufacturing and marketing the fixed-dose combination drug, Teneligliptin plus Metformin plus Dapagliflozin Film-coated bilayered tablet.
This came after the firm presented its justification for a Phase III clinical trial study waiver for the proposed FDC based on Phase III clinical trial study conducted on FDC of Dapagliflozin plus Teneligliptin (5mg+20mg & 10mg+20mg) tablets.
Teneligliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor. Teneligliptin inhibits the action of DPP-4 enzymes and slows down the rapid degradation of incretins. It also increases insulin synthesis by the pancreas and decreases glucagon levels which are a counter-hormone of insulin, thereby further decreasing blood sugar levels.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome (PCOS). Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years old with type 2 diabetes mellitus.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. By inhibiting SGLT2, dapagliflozin blocks the reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity.
At the recent SEC meeting for Endocrinology and Metabolism held on the 20th and 21st of April 2023, the expert panel reviewed the justification for Phase III CT study waiver for the proposed FDC based on Phase III clinical trial study conducted on FDC of Dapagliflozin plus Teneligliptin (5mg+20mg & 10mg+20mg) tablets.
The Committee noted that the firm has conducted a Phase III CT study for the FDC of Dapagliflozin plus Teneligliptin (5mg+20mg & 10mg+20mg) tablets along with background therapy with Metformin.
After detailed deliberation, the committee considered the request of the firm for Phase III CT waiver and recommended for grant of permission to manufacture and market the product with the condition that a Phase IV clinical trial should be conducted.
Accordingly, the expert panel directed that the Phase IV clinical trial protocol should be submitted to CDSCO within 03 months from the date of approval for review by the SEC.