CDSCO Panel Grants Roche's Protocol Amendment Proposal For Crovalimab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche's protocol amendment proposal for the clinical trial titled "A study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab in pediatric participants with the atypical hemolytic uremic syndrome (aHUS) (COMMUTE-p)".
This came after the drug major Roche presented protocol amendment version 4 dated 29 July 2022 and version 5 dated 18 May 2023, protocol No.:BO42354. This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
Atypical hemolytic uremic syndrome (aHUS) is a sporadic genetic disease that causes tiny blood clots to form in blood vessels, blocking blood flow to important organs. aHUS can cause kidney failure, heart disease, and other serious health problems.
Crovalimab is a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. By blocking the cleavage of C5 to C5a and C5b, it is expected to inhibit complement activation, which is the cause of some diseases.
Crovalimab is under development for the treatment of vaso-occlusive crisis associated with sickle cell disease, paroxysmal nocturnal hemoglobinuria, lupus nephritis, and atypical hemolytic uremic syndrome (aHUS).
At the recent SEC meeting for Renal on 20th February 2024, the expert panel reviewed the proposal presented by the drug major Roche for protocol amendment version 4 dated 29 July 2022, and protocol amendment version 5 dated 18 May 2023, protocol No.:BO42354.
After detailed deliberation, the committee approved the amendments as presented by the firm.
