Ajanta Pharma Gets CDSCO Panel Nod To Study Antihypertensive FDC
New Delhi: Ajanta Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a bioequivalence (BE) study of the antihypertensive fixed-dose combination drug Bisoprolol Fumarate plus Telmisartan plus Chlorthalidone film-coated tablet.
The committee also stated that the firm should submit a BE study report to CDSCO for further review by the committee for making decisions on the Phase III clinical trial protocol.
This came after the firm presented its proposal along with the revised BE study protocol before the committee.
Bisoprolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication belongs to a class of drugs known as beta blockers.
Bisoprolol reduces the oxygen consumption of myocardial cells, relieving the heart's workload. B1 receptors are also present in the juxtaglomerular cells of the kidneys. By blocking these receptors, bisoprolol reduces the release of renin, thereby blocking the activation of the renin-angiotensin system.
Telmisartan is used in the treatment of Hypertension (high blood pressure), Heart failure, and prevention of heart attack and stroke. Telmisartan is an angiotensin receptor blocker (ARB). It relaxes blood vessels by blocking the action of a chemical that usually makes blood vessels tighter.
Telmisartan interferes with the binding of angiotensin II to the angiotensin II AT1 receptor by binding reversibly and selectively to the receptors in vascular smooth muscle and the adrenal gland. As angiotensin II is a vasoconstrictor, which also stimulates the synthesis and release of aldosterone, blockage of its effects results in decreases in systemic vascular resistance.
Chlorthalidone is used for Hypertension (high blood pressure) and Edema. It treats edema (fluid overload) associated with heart, liver, kidney, or lung disease. Chlorthalidone is a diuretic that lowers blood pressure by removing extra water and certain electrolytes from the body. Over time it also relaxes blood vessels and improves blood flow.
Chlorthalidone exerts its therapeutic action by antagonizing sodium-chloride symporter in the distal convoluted tubule of the nephron. It is similar to a thiazide diuretic in its mechanism of action, although it has a mildly altered chemical structure.
At the recent SEC meeting for Cardiovascular and Renal held on 7th November 2023, the expert panel reviewed the proposal along with the revised BE study of the FDC Bisoprolol Fumarate plus Telmisartan plus Chlorthalidone film-coated tablet presented by drug major Ajanta Pharma.
After detailed deliberation, the expert panel recommended the grant of permission to conduct the proposed BE study.
Accordingly, the committee suggested that the firm should submit a BE study report to CDSCO for further review by the committee for making decisions on the Phase III clinical trial protocol.
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