CDSCO panel approves GSK pharma's protocol amendment proposal for Mepolizumab Powder for Solution for Injection
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major GSK Pharma's proposal for amendment of protocol for conduct of Phase IV study of Mepolizumab Powder for Solution for Injection 100mg.
This recommendation came after the firm presented the proposal for amendment of protocol for the conduct of Phase IV study of Mepolizumab Powder for Solution for Injection 100mg.
Mepolizumab is a fully-humanized monoclonal IgG1 kappa anti-IL-5 antibody used in conjunction with other therapies to treat severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
Mepolizumab binds with high affinity to IL-5, thus preventing its interaction with the IL-5 receptor expressed by eosinophils and, to a lesser extent, also by basophils.
At the recent SEC meeting for Pulmonary held on 4th November 2022, the expert panel reviewed the proposal for amendment for a protocol for the conduct of Phase IV study of the monoclonal antibody Mepolizumab Powder for Solution for Injection 100mg.
After detailed deliberation, the committee recommended the grant of approval for amendment in the Phase IV study protocol No. 209682, amendment no. 04 dated 23 Aug 2022 as presented by the firm in line with Prescribing Information of the product.
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