Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Empagliflozin plus Sitagliptin FDC
New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) antidiabetic drug for two strengths, i.e. Empagliflozin 10 mg/25 mg plus Sitagliptin 100 mg/100 mg film-coated tablet.
This came after Exemed Pharmaceutical presented the proposal along with a Phase III clinical trial report for two strengths, i.e. Empagliflozin 10 mg/25 mg plus sitagliptin 100 mg/100 mg film-coated tablet, before the committee.
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.
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. Sitagliptin was granted FDA approval on October 16, 2006.
Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control, which is demonstrated by reduced glycosylated hemoglobin (HbA1c).
At the recent SEC meeting for endocrinology and metabolism held on 22nd August 2024, the expert panel reviewed the proposal along with the Phase III clinical trial report for two strengths, i.e. empagliflozin 10mg/25mg plus sitagliptin 100 mg/100 mg film-coated tablet, before the committee.
After detailed deliberation, the committee recommended a grant of permission to the manufacturer and market of the proposed FDC.
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