CDSCO tells Sandoz to review and report PSUR data of Brolucizumab injection

Published On 2022-11-27 07:30 GMT   |   Update On 2022-11-27 07:30 GMT

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Sandoz to review all the Periodic safety update reports (PSUR) data for Brolucizumab injection 120 mg/ml and present a summarized report of the PSUR data along with the Phase IV study report after completion of the study for further...

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Sandoz to review all the Periodic safety update reports (PSUR) data for Brolucizumab injection 120 mg/ml and present a summarized report of the PSUR data along with the Phase IV study report after completion of the study for further evaluation.

This came after the firm presented an interim safety analysis report of the ongoing Phase IV clinical trial for Brolucizumab injection 120 mg/ml as per the recommendation of the SEC Ophthalmology meeting held on November 5th, 2021.

The committee noted the results of the interim safety analysis of patients who have competed for one dosing of the drug.

In addition, the committee also noted that the firm has submitted three PSUR data to CDSCO up till and there was no additional safety signal identified as informed by the firm.

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits.

Brolucizumab is a monoclonal antibody indicated to treat neovascular age-related macular degeneration. Brolucizumab is a vascular endothelial growth factor (VEGF) inhibitor that targets the major VEGF-A isoforms: VEGF110, VEGF121, and VEGF165. Inhibition of these VEGF-A isoforms reduces the proliferation of endothelial cells, vascularization of the tissue, and permeability of the vasculature.

At the recent SEC meeting for Ophthalmology held on 28th October 2022, the expert panel reviewed the interim safety analysis report of the ongoing Phase IV clinical trial of the Ophthalmic drug Brolucizumab injection 120 mg/ml
After detailed deliberation, the committee opined that the firm should review all the PSUR data of the drug and present a summarized report of the PSUR data along with the Phase IV study report after the completion of the study for further evaluation by the committee.
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