CDSCO panel rejects Akum Pharma's proposal to study Roxadustat Tablets
New Delhi: Raising safety concerns with the drug Roxadustat, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected Akums Drugs and Pharmaceuticals' proposal to conduct the bioequivalence study along with Phase III clinical trial waiver with drug Roxadustat tablets 20mg/ 50mg /70mg /100mg/ 150mg.
This came after the drug major Akums Drugs and Pharmaceuticals presented the proposal for a grant of permission to conduct a bioequivalence study along with a Phase III clinical trial waiver with the drug Roxadustat tablets 20mg/ 50mg /70mg /100mg/ 150mg.
Roxadustat is a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor used to treat symptomatic anemia associated with chronic kidney disease. It works by reducing the breakdown of the hypoxia-inducible factor (HIF), which is a transcription factor that stimulates red blood cell production in response to low oxygen levels. Roxadustat was first approved by the European Commission in August 2021.
Earlier, the Medical Dialogues Team had reported that the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) under the Food and Drug Administration (FDA) in the United States had unanimously voted to disprove the use of Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients.
At the recent SEC meeting for cardiovascular and renal, the expert panel reviewed the proposal presented by Akums Drugs and Pharmaceuticals to conduct a bioequivalence study along with a Phase III clinical trial waiver with the drug Roxadustat tablets 20mg/ 50mg /70mg /100mg/ 150mg.
After detailed deliberation, the committee noted that there are safety concerns with the drug Roxadustat and the United States Food and Drug Administration (USFDA) has raised safety concerns with respect to thrombotic complications including myocardial infarction.
In line with the above observation, the committee did not recommend for grant of permission to conduct a bioequivalence study along with a Phase III clinical trial waiver.
Furthermore, the committee recommended for withdrawal/suspension of the bioequivalence study and clinical trial permission granted to other applicants with the drug Roxadustat, if any.
Also Read:FDA panel votes against use of Roxadustat for anaemia in CKD patients
