Submit raw data linked to CT result: CDSCO Panel Tells Akum Pharma on Azelnidipine, Metoprolol FDC drug
New Delhi: Based on the justification presented by Akum Pharmaceutical with respect to the clinical trial results of the fixed-dose combination (FDC) drug Azelnidipine plus Metoprolol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the raw data of the clinical trial.
This came after the firm presented its proposal along with clarification/justification with respect to clinical trial results of the FDC cardiovascular drug Azelnidipine 8mg/8mg/16mg/16mg)plus Metoprolol (25mg/ 50mg/25mg/50mg) sustained released (SR) tablet.
Azelnidipine is a medicine used to treat high blood pressure. It belongs to a group of medicines that block the calcium channels in the blood vessels. It works by relaxing the blood vessels in patients with high blood pressure.
Azelnidipine inhibits trans-membrane Ca2+ influx through the voltage-dependent channels of smooth muscles in vascular walls. Ca2+ channels are classified into various categories, including L-type, T-type, N-type, P/Q-type, and R-type Ca2+ channels.
Metoprolol is a beta-1-adrenergic receptor inhibitor specific to cardiac cells with negligible effect on beta-2 receptors. Metoprolol is a medication that lowers your blood pressure and heart rate, making it easier for the heart to pump blood to the rest of your body. It treats high blood pressure. It also prevents chest pain or further damage after a heart attack.
Earlier, the Medical Dialogues Team had reported that the Central Drug Standard Control Organisation (CDSCO) panel had opined Akum Pharmaceuticals to submit detailed clarification/justification regarding the study of the fixed-dose combination drug (FDC) Azelnidipine plus Metoprolol tablet.
In continuation, at the recent SEC meeting for the Cardiovascular and renal held on 11 October 2023, the expert panel reviewed the proposal presented by Akum Pharmaceuticals along with clarification or justification with respect to clinical trial results of the FDC Azelnidipine plus Metoprolol (SR) tablet.
After detailed deliberation, the committee opined that the firm should submit raw data from the clinical trial to the CDSCO for review by the committee.
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