Dosing schedule and duration not defined: CDSCO panel tells Windlas Biotech on antihypertensive FDC Drug

Published On 2022-10-01 11:30 GMT   |   Update On 2023-10-18 09:32 GMT
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New Delhi: Citing that dosing schedule and duration was not defined, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined Windlas Biotech to present detailed justifications regarding the fixed dose combination (FDC) anti-hypertensive drug Bi

soprolol Fumarate IP 2.5mg/5mg/10mg plus Telmisartan IP 20mg/40mg/80mg plus Chlorthalidone IP 6.25mg / 12.5mg/12.5mg uncoated tablets.

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This recommendation came after Windlas Biotech presented their proposal for proposed FDC which is Bisoprolol Fumarate IP 2.5mg/5mg/10mg plus Telmisartan IP 20mg/40mg/80mg plus Chlorthalidone IP 6.25mg / 12.5mg/12.5mg uncoated tablet.

Bisoprolol is a beta-1 adrenergic blocking agent used to prevent myocardial infarction and heart failure and to treat mild to moderate hypertension. Bisoprolol is a competitive, cardioselective β1-adrenergic antagonist. When β1-receptors (located mainly in the heart) are activated by adrenergic neurotransmitters such as epinephrine, both the blood pressure and heart rate increase, leading to greater cardiovascular work, increasing the demand for oxygen. Bisoprolol reduces cardiac workload by decreasing contractility and the need for oxygen through competitive inhibition of β1-adrenergic receptors.

Telmisartan is an ARB used to treat hypertension, diabetic nephropathy, and congestive heart failure. Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan works by blocking the vasoconstrictor and aldosterone secretory effects of angiotensin II.

Chlorthalidone is a diuretic used to treat hypertension or edema caused by heart failure, renal failure, hepatic cirrhosis, estrogen therapy, and other conditions. Chlorthalidone prevents reabsorption of sodium and chloride through inhibition of the Na+/Cl- symporter in the cortical diluting segment of the ascending limb of the loop of Henle. Reduction of sodium reabsorption subsequently reduces extracellular fluid and plasma volume via an osmotic, sodium-driven diuresis. By increasing the delivery of sodium to the distal renal tubule, Chlorthalidone indirectly increases potassium excretion via the sodium-potassium exchange mechanism.

The proposal presented by Windlas Biotech was minutely scrutinized by the SEC Committee at its latest SEC meeting for Cardiovascular & Renal.
After detailed deliberation, the committee opined that:
1. The firm should present the justification and essentiality for the proposed FDC.
2. The dosing schedule and duration was not defined for proposed FDC.
3. Scientific justification with rationality along with published literature in peer reviewed journals in support of FDC to be presented
4. Justification for proposed indication was not presented.
In view of the above, the committee recommended that the firm should present the justification for aforesaid points before the SEC for further consideration.

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