Torrent Pharma Receives SEC Approval to Market Alogliptin-Metformin FDC, Asked to Conduct Phase IV Trial
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to Torrent Pharmaceuticals to manufacture and market its proposed Fixed-Dose Combination (FDC) of Alogliptin benzoate 17 mg (equivalent to Alogliptin 12.5 mg) and Metformin Hydrochloride IP 850 mg (equivalent to Metformin 663 mg) film-coated tablets.
However, the nod is subject to the condition that the firm should conduct a Phase IV clinical trial.
This came after the firm presented justification and rationality for the proposed strength of the FDC of Alogliptin benzoate 17 mg (equivalent to Alogliptin 12.5 mg) and Metformin Hydrochloride IP 850 mg (equivalent to Metformin 663 mg) film-coated tablets before the committee.
The committee noted that the proposed FDC is already approved in UK, EU, Canada and Australia.
Alogliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to treat hyperglycemia in patients with type 2 diabetes mellitus.
Alogliptin inhibits dipeptidyl peptidase 4 (DPP-4), which normally degrades the incretins glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1). The inhibition of DPP-4 increases the amount of active plasma incretins, which helps with glycemic control. GIP and GLP-1 stimulate glucose-dependent secretion of insulin in pancreatic beta cells. GLP-1 has the additional effects of suppressing glucose-dependent glucagon secretion, inducing satiety, reducing food intake, and reducing gastric emptying.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. Metformin's mechanisms of action are unique from other classes of oral antihyperglycemic drugs. Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the justification and rationality for the proposed strength of the FDC of Alogliptin benzoate 17 mg (equivalent to Alogliptin 12.5 mg) and Metformin Hydrochloride IP 850 mg (equivalent to Metformin 663 mg) film-coated tablets presented by Torrent Pharmaceuticals.
After detailed deliberation, the committee considered the request for BE and the Phase III CT waiver and recommended grantingpermission for the manufacturing and marketing of the proposed FDC with the condition to conduct a Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC for review by the committee.
