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  • Submit Source Data of...

Submit Source Data of Phase III CT Report: CDSCO Panel Tells Eris Lifesciences on Metoprolol Succinate plus Dapagliflozin FDC

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-05-11T18:00:32+05:30  |  Updated On 11 May 2024 6:00 PM IST
Eris Lifesciences transfers 100% stake in 2 arms to Eris Therapeutics for Rs 861.9 crore
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New Delhi: Reviewing the Phase III clinical trial report of fixed-dose combination (FDC) drug, Metoprolol Succinate sustained released 25mg/50mg plus Dapagliflozin 5mg/10mg tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Eris Lifescience to submit source data of the Phase III clinical trial report of the proposed drug.
This came after Eris Lifescience presented the proposal along with the Phase III clinical trial report before the committee.

Metoprolol is a selective beta-1 blocker commonly employed as the succinate and tartrate derivatives depending if the formulation is designed to be of immediate release or extended release. Metoprolol is a beta-1-adrenergic receptor inhibitor specific to cardiac cells with negligible effect on beta-2 receptors. This inhibition decreases cardiac output by producing negative chronotropic and inotropic effects without presenting activity towards membrane stabilization nor intrinsic sympathomimetics.

Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. By inhibiting SGLT2, dapagliflozin blocks the reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity. Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction.

At the recent SEC meeting for Cardiovascular held on 23rd April 2024, the expert panel reviewed the proposal presented by the drug major Eris Lifscience along with the Phase III clinical trial report of the cardiovascular drug combination Metoprolol Succinate plus Dapagliflozin tablets.
After detailed deliberation, the committee opined that Eris Lifscience should submit source data of the Phase III clinical trial report to CDSCO for review by the committee.
Also Read:Bharat Biotech International Gets CDSCO Panel Nod to Study Mycobacterium Tuberculosis Live Attenuated Vaccine
metoprololdapaglifozineris lifesciencescdscophase 3 trial
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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