CDSCO Panel grants AstraZeneca Pharma’s proposal to include self-administration in package insert of Benralizumab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major AstraZeneca Pharma’s proposal to revise the package insert for Benralizumab 30 mg/ml solution for injection with respect to the inclusion of instructions for self-administration of the drug by the patient or caregiver.
This came after AstraZeneca Pharma India presented the proposal for revision in the package insert, vide version 4.0 dated 10.02.2023 with respect to the inclusion of instructions for self-administration of the drug by the patient /caregiver.
The committee has noted that the PFS presentation of the drug is already approved for the subcutaneous route and proposed for self-administration of the drug by the patient/caregiver.
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 high affinity for the FcγRIIIα receptor in natural killer cells, macrophages and neutrophils.
Benralizumab is indicated as a maintenance treatment of patients 6 years or older with severe asthma and an eosinophilic phenotype. Benralizumab injection is used together with other medicines to treat severe asthma in patients whose asthma is not controlled with their current asthma medicines. This medicine helps prevent severe asthma attacks (exacerbations) and can improve your breathing.
At the recent SEC meeting for pulmonary held on August 6, 2024, the expert panel reviewed the proposal for revision in the package insert with respect to the inclusion of instructions for self-administration of the drug by the patient /caregiver.
After detailed deliberation, the committee recommended approval of the revision in the package insert vide version 4.0 dated 10.02.2023 for inclusion of instructions for self-administration of drug by patient/caregiver.
