CDSCO Panel Approves Novo Nordisk Proposal Amendment Proposal for Etavopivat study
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.
