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  • Novo Nordisk Gets...

Novo Nordisk Gets CDSCO Panel Nod To Study Etavopivat

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-30T18:00:13+05:30  |  Updated On 30 Aug 2024 6:00 PM IST
CagriSema demonstrates superior weight loss in adults with obesity, type 2 diabetes in REDEFINE 2 trial: Novo Nordisk
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New Delhi: The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of Etavopivat.

This came after the drug maker Novo Nordisk presented Phase III clinical trial protocol No. NN7535-7807 version No.1.0 dated 18.04.2024.

Etavopivat is an investigational, oral, small-molecule activator of erythrocyte pyruvate kinase (PKR) in development for the treatment of sickle cell disease (SCD) and other hemoglobinopathies.

PKR activation is proposed to ameliorate the sickling of SCD red blood cells (RBCs) through multiple mechanisms, including reduction of 2,3-diphosphoglycerate (2,3-DPG), which consequently increases hemoglobin (Hb)-oxygen affinity; increased binding of oxygen reduces sickle hemoglobin polymerization and sickling. In addition, PKR activation increases adenosine triphosphate (ATP) produced via glycolytic flux, which helps preserve membrane integrity and RBC deformability.

Etavopivat, a small molecule activator of the glycolytic enzyme erythrocyte pyruvate kinase, decreased 2,3-diphosphoglycerate in red blood cells (RBCs) from nonhuman primates and healthy subjects and significantly increased hemoglobin (Hb)-oxygen affinity in healthy subjects. Using ex vivo RBCs from donors with sickle cell disease (SCD) (homozygous hemoglobin S or hemoglobin S and C genotype), etavopivat increased Hb-oxygen affinity and reduced sickling under deoxygenation.

At the recent SEC meeting for Hematology held on 8th August 2024, the expert panel reviewed the Phase III clinical trial protocol No. NN7535-7807 version No.1.0 dated 18.04.2024.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read: Revise Phase III CT Protocol: CDSCO Panel Tells Windlass Biotech on FDC Tamsulosin Hydrochloride plus Mirabegron

NovoNordiskcdscoNovo NordiskEtavopivatsickle cell anemia
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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