Exemed Gets CDSCO Panel Nod To study dapagliflozin, Sacubitril, Valsartan as Sodium salt tablet
New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study and Phase III clinical trial of the fixed-dose combination (FDC) of Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg/5mg/5mg plus Sacubitril and Valsartan as Sodium salt complex 50mg (24mg and 26mg), 100mg (49mg and 51mg) and 200mg (97mg and 103mg) tablet.
This came after the firm presented its proposal along with the BE study protocol and Phase III clinical trial protocol before the committee.
The combined use of sacubitril/valsartan and dapagliflozin is associated with improved cardiac function in patients affected by heart failure (HF) with reduced ejection fraction (HFrEF).
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor. Sodium-glucose cotransporter 2 is responsible for the reabsorption of approximately 90% of the urinary glucose in the proximal tubule of the nephron. Inhibition of SGLT2 induces glucosuria, which is more pronounced in hyperglycemic individuals owing to the higher amounts of glucose filtered into the urine. The effect of glucosuria diminishes with the normalizing of blood glucose levels. Among individuals with HFrEF, with or without diabetes mellitus, the addition of dapagliflozin has been associated with decreased rates of cardiovascular (CV) death or worsening heart failure (HF), as well as all-cause mortality
Sacubitril is a prodrug neprilysin inhibitor used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure and reduced ejection fraction.
Valsartan is an angiotensin-receptor blocker used to manage hypertension alone or in combination with other antihypertensive agents and to manage heart failure in patients who are intolerant to ACE inhibitors.
At the recent SEC meeting for cardiovascular and renal held on 11th October 2023, the expert panel reviewed the BE study protocol and Phase III clinical trial protocol of the Dapagliflozin Propanediol Monohydrate plus Sacubitril and Valsartan as Sodium salt complex presented by Exemed Pharmaceutical.
After detailed deliberation, the committee recommended granting permission to conduct the BE study and Phase III clinical trial.
In addition, the expert panel suggested that the result of the BE study should be presented for review by the SEC before initiating the Phase III clinical trial.
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