AstraZeneca gets CDSCO panel nod to study lupus erythematosus drug Anifroluma
New Delhi: In a significant development, drug-major AstraZeneca has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct a study of Anifrolumab that is indicated in the treatment of moderate to severe systemic lupus erythematosus.
This comes in the wake of the Phase III clinical trial protocol D3466C00001 version no 1.0 dated 28/07/2021presented by AstraZeneca at the recent SEC meeting for Cardiovascular & Renal.
Anifrolumab is a type 1 interferon receptor (IFNAR) inhibiting IgG1κ monoclonal antibody indicated in the treatment of adults with moderate to severe systemic lupus erythematosus.
Systemic lupus erythematosus (SLE) is an autoimmune disorder affecting multiple systems in the body. SLE may manifest as a rash on the skin, and can progress to life-threatening autoimmune reactions in the kidney or nervous system.
The standard therapy for systemic lupus erythematosus consists of antimalarials like hydroxychloroquine, glucocorticoids like dexamethasone, and disease modifying antirheumatic drugs like methotrexate.
Anifrolumab is a monoclonal antibody that inhibits type 1 interferon receptors, indicated in the treatment of moderate to severe systemic lupus erythematosus. Anifrolumab was granted FDA approval on 30 July 2021.
At the recent SEC meeting, the committee noted that the safety profile of trial drug from various pre-clinical toxicity studies and clinical studies, may justify the conduct of the proposed trial.
In respect to the innovations vs existing therapeutic option, the SEC minutes added, "the primary objective of the study is to evaluate the efficacy of Anifrolumab compared with placebo as added to SOC in active proliferative LN on the proportion of participants achieving CRR."
Further, regarding the unmet medical need in the country, the committee observed that there is a need for new, effective, and safe therapies targeting novel pathways that remains for treatment of active LN to improve renal remission rates, reduce flares, and prevent ESKD while reducing the need for glucocorticoids. The trial drug may be an alternative treatment option in subjects with active proliferative lupus nephritis.
After detailed deliberation, the committee recommended for grant of permission to conduct the study in its presented form.
