CDSCO Panel Allows Ravenbhel to Conduct BE, Phase III Trial of Dapagliflozin, Sacubitril, Valsartan FDC
Drug Trials at PMCH Get Boost with Formation of Ethical Panel
New Delhi: Ravenbhel Healthcare has got the go-ahead from the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organization (CDSCO), to conduct the bioequivalence study and Phase III clinical trial of a fixed-dose combination of Dapagliflozin Propanediol Monohydrate plus Sacubitril and Valsartan as a sodium salt complex film-coated tablet.
This came after the firm presented their proposal along with the bioequivalence (BE) study protocol and Phase III clinical trial protocol for Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg/5 mg/5 mg + Sacubitril and Valsartan as a sodium salt complex 24 mg and 26 mg/49mg and 51 mg/97mg and 103 mg film-coated tablet before the committee.
Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine.
Sacubitril is a prodrug neprilysin inhibitor used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) 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, the expert panel reviewed the proposal along with the bioequivalence (BE) study protocol and Phase III clinical trial protocol for Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg/5 mg/5 mg + Sacubitril and Valsartan as a sodium salt complex 24 mg and 26 mg/49 mg and 51 mg/97 mg and 103 mg film-coated tablet before the committee.
After detailed deliberation, the committee recommended for the grant of permission to conduct the BE study and Phase III clinical trial.
Accordingly, the expert panel suggested that the result of the BE study should be submitted to CDSCO for further review by the committee before initiation of the Phase III clinical trial.
