Justify Sample Size: CDSCO Panel Tells Windlas Biotech on Cardiovascular FDC

This came after Windlas Biotech presented the proposal along with the BE study report along with the Phase III clinical trial protocol before the committee.

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 also used to prevent chest pain caused by angina.

Telmisartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Chlorthalidone is a medication used in the management and treatment of hypertension. It is in the thiazide-like diuretics class of drugs. This activity reviews chlorthalidone's indications, action, and contraindications as a valuable agent in managing hypertension, edema, and calcium nephrolithiasis.

At the recent SEC meeting for Cardiovascular held on 23rd April 2024, the expert panel reviewed the proposal for the BE study report along with the Phase III clinical trial protocol of the fixed-dose combination Bisoprolol Fumarate plus Telmisartan plus Chlorthalidone.

After detailed deliberation, the committee opined that the firm should submit the justification for sample size in light of intra-subject variability observed for the drug Telmisartan in the BE study report.

Furthermore, the committee recommended that the firm submit the revised structured Phase III CT Protocol as per NDCT Rules, 2019 for review by the committee.