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This followed the company’s submission of a proposal, along with its justification, seeking a waiver of bioequivalence (BE) and Phase III clinical trial (CT) requirements for the fixed-dose combination (FDC) of Sitagliptin phosphate monohydrate equivalent to Sitagliptin 50 mg/50 mg, Glimepiride 0.5 mg/0.5 mg, and Metformin hydrochloride 500 mg/1000 mg film-coated tablets before the committee.
A fixed-dose combination (FDC) of sitagliptin, glimepiride, and metformin is a triple-drug therapy used to treat type 2 diabetes. It is an adjunct to diet and exercise for adults whose blood sugar levels are not adequately controlled with a dual or single medication regimen.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar.
Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes.
At the recent SEC meeting for Endocrinology and Metabolism, the expert panel presented the proposal along with justification for BE and Phase III CT waiver before the committee.
After detailed deliberation, the committee opined the following:
1. Firm did not present any data for the proposed strength of the FDC.
2. Lower dose of Glimepiride adding to Sitagliptin and Metformin hydrochloride once daily is clinically not useful.
3. The product is not approved internationally.
In line with this, the committee did not recommend approval of the proposed FDC.
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