Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan
New Delhi: The drug major Synokem 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 of the fixed-dose combination (FDC) Dapagliflozin Propanediol Monohydrate plus Sacubitril plus Valsartan Sodium Salt Film Coated Tablets.
This came after Synokem Pharmaceutical presented its proposal and the BE study protocol before the committee.
Dapagliflozin works by increasing the removal of sugar by your kidneys. Dapagliflozin is also used to treat kidney disease and heart failure. It helps to lower the risk of death from heart disease and reduces the need to go to a doctor or hospital to treat heart failure.
The propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.
Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
Sacubitril acts by preventing the breakdown of endogenous vasoactive peptides, including natriuretic peptides (ANP, BNP, and CNP), thereby limiting myocardial cell death.
Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. Valsartan relaxes the blood vessels and lowers blood pressure
At the recent SEC meeting for Cardiovascular held on 20th February 2024, the expert panel reviewed the proposal presented by drug maker Synokem to conduct the BE study of the FDC Dapagliflozin Propanediol Monohydrate plus Sacubitril plus Valsartan Sodium Salt Film Coated Tablets.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE Study.
Accordingly, the expert panel suggested that the firm should submit the BE study report for review by the committee and for taking further decisions on the Phase III clinical trial protocol.
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