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  • CDSCO Panel Approves...

CDSCO Panel Approves Novo Nordisk Proposal Amendment Proposal for Etavopivat study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-02-09T17:45:27+05:30  |  Updated On 9 Feb 2025 5:45 PM IST
As Ozempic, Wegovy Take Priority, Novo Nordisk Winds Down Insulin Portfolio In India
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by pharmaceutical major Novo Nordisk to study Etavopivat 200 mg in people with sickle cell disease.

This came after the firm presented protocol amendment version 3.0 dated 30 Sep 2024 protocol no. NN7535-7807 (HIBISCUS 2).

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve exercise tolerance, and reduce fatigue in people with sickle cell disease. The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.

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.

At the recent SEC meeting for hematology held on January 16, 2025, the expert panel reviewed protocol amendment version 3.0 dated 30 Sep 2024 protocol no. NN7535-7807 (HIBISCUS 2).

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal for Anti-cancer Drug Volrustomig study

EtavopivatcdscoNovo Nordiskprotocol amendmentsickle 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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