Novo Nordisk has received Subject Expert Committee (SEC) approval from India’s Central Drug Standard Control Organization (CDSCO) to conduct Phase III clinical trials of etavopivat in the treatment of sickle cell disease (SCD). The proposed trial will evaluate the oral medication, which is a small-molecule activator of erythrocyte pyruvate kinase (PKR) that has been developed as a treatment option for SCD and other hemoglobinopathies.
This approval follows Novo Nordisk’s presentation of the first version of the Phase III clinical trial (protocol No. NN7535-7807) from April of this year. Etavopivat aims to ameliorate the sickling of red blood cells in SCD patients through multiple mechanisms, including increasing oxygen-hemoglobin affinity and the preservation of red blood cell membrane integrity.
At OxyDial, we’re extremely interested in Novo Nordisk’s progress and the development of etavopivat as a new treatment for SCD. The advancement to Phase III represents a significant step towards bringing these kinds of innovative new therapies to thousands of patients living with this challenging blood disorder. We’re eager to see how etavopivat can help improve disease management and quality of life for those affected by SCD worldwide.
Read more: https://lnkd.in/evkA_jaV
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