Dr Reddy's gets CDSCO panel nod to study Darbepoetin alfa

Published On 2023-03-01 12:30 GMT | Update On 2023-03-01 12:30 GMT

New Delhi: The drug major Dr Reddy's Laboratories has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the pharmacokinetic/ pharmacodynamic (PK/PD) clinical trial of the Darbepoetin alfa which is used to treat anaemia.

However, this approval is subject to condition that the range of the haemoglobin during a screening of the subjects should be 12-14 gm/dl and the complete iron profile should be monitored including serum iron, total iron-binding capacity (TIBC), transferrin saturation and serum creatinine.

This came after the firm presented the proposal for the conduct of a PK/PD clinical trial titled “A single dose, double-blind, two-period crossover, balanced sequences, comparative pharmacokinetic study with separate comparisons of three pairs of products of DRL- Darbepoetin (DRL_DA), US licensed reference Product (Aranesp), and EU approved reference Medicinal Product (Aranesp), administered by the subcutaneous route to male healthy volunteers vide Protocol number: DA-01-006; version 1.0 dated 04.08.2022”.

Darbepoetin alfa is a recombinant form of human erythropoietin used to increase the differentiation of progenitor cells to red blood cells in the treatment of anaemia.

Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. The binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates the activation of JAK-STAT signalling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.

At the recent SEC meeting for Cardiovascular and Renal held on 21st February 2023, the expert panel reviewed the proposal presented by drug major Dr Reddy's to conduct the PK/PD clinical trial of Darbepoetin alfa.

After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial subject to the following conditions:

1. The range of hemoglobin during a screening of the subjects should be 12-14 gm/dl.

2. The complete iron profile should be monitored including serum iron, TIBC, transferrin saturation and serum creatinine.

Accordingly, the expert panel directed that the firm should submit the revised protocol to CDSCO for approval.

Also Read:Submit justification: CDSCO panel tells Hetero for FDC Lacosamide, Brivaracet

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Dr. Divya Colin

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.

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Dr Reddy's gets CDSCO panel nod to study Darbepoetin alfa

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