Roche gets CDSCO panel nod to study Crovalimab
New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDCSO) to conduct a Phase III clinical study of Crovalimab indicated to treat atypical Hemolytic Uremic Syndrome.
This came after the drug major Roche presented the proposal for Phase III study protocol No. BO42354 version 3 dated 08 April 2022.
The Study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS). This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.
Atypical hemolytic uremic syndrome (aHUS) is a very rare 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 (RG6107) 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 a number of 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).
Last year, at the 114th SEC meeting, held on 24.11.2022 at CDSCO, in response to the Phase III study protocol for Crovalimab 340mg/2ml presented by drug major Roche, the expert panel had suggested the firm modify the inclusion and exclusion criteria with respect to the protocol as discussed during the presentation.
Now, in continuation, at the recent SEC meeting for Cardiovascular and Renal held on 9th August 2023, the expert panel reviewed the proposal presented by the drug major Roche to conduct the Phase III study protocol No BO42354 version 3 dated 08 April 2022.
After detailed deliberation, the committee recommended granting permission to conduct the proposed study.
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