CDSCO Panel approves AstraZeneca Pharma's Benralizumab solution for Injection in auto-injector
New Delhi: Granting the local phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca Pharma's Benralizumab solution for Injection 30 mg/ml in auto-injector for the indication of “as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients”.
However, this approval is subject to the condition that the firm should conduct the Phase IV clinical trial to generate more data on the Indian population with respect to the safety, functionality, and reliability of the auto-injector.
Benralizumab is a monoclonal antibody used to treat severe eosinophilic asthma. Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin 5 receptor (IL-5R) expressed on eosinophils and basophils. It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking signal transduction. It is an afucosylated IgG which gives it a high affinity for the FcγRIIIα receptor in natural killer cells, macrophages, and neutrophils.
At the recent SEC meeting for Pulmonary held on 21st May 2024, the expert panel reviewed the proposal for approval of Benralizumab solution for Injection 30 mg/ml in Auto-injector for the indication of “as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients” with request of local phase-III trial waiver.
After detailed deliberation, the committee has recommended approval of Benralizumab solution for Injection 30 mg/ml in auto-injector with a waiver of phase III local clinical trial with the condition to conduct the Phase IV clinical trial to generate more data in the Indian population concerning safety, functionality, and reliability of auto-injector.
