CDSCO Panel Grants AstraZeneca's Protocol Amendment Proposal for Anifrolumab
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-01-04 11:30 GMT | Update On 2024-03-22 17:03 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSO has approved the drug major's AstraZeneca protocol amendment proposal for the Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis.
This came after the firm presented Protocol amendment version 2.1 dated 18 September 2023, protocol no. D3466C00001.
The above study is a Phase 3 study of Anifrolumab in adult patients with active proliferative lupus nephritis (IRIS). The purpose of this study is to evaluate the efficacy and safety of IV Anifrolumab in adult patients with Active Proliferative Lupus Nephritis.
Anifrolumab is a monoclonal antibody that inhibits type 1 interferon receptors, indicated in the treatment of moderate to severe systemic lupus erythematosus.
Anifrolumab is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor, blocking the activity of all type I interferons including IFN-alpha, IFN-beta, and IFN-omega. Type I interferons are cytokines involved in the inflammatory pathways.
At the recent SEC meeting for cardiovascular and renal held on 6th and 7th December 2023, the expert panel reviewed the protocol amendment version 2.1 dated 18 September 2023, protocol no. D3466C00001.
After detailed deliberation, the committee recommended approval of the Protocol amendment as presented by the firm.
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