Conduct CT in Indian population: CDSCO Panel Tells AstraZeneca for Anifrolumab

Written by Dr. Divya Colin Published On 2022-12-19T18:00:21+05:30 | Updated On 19 Dec 2022 6:00 PM IST

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New Delhi: Highlighting that the there is no study data available in Indian population for monoclonal antibody Anifrolumab 150mg/ml concentrate for solution for infusion, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major AstraZeneca that the firm should conduct clinical trial in Indian population.

This came after the firm presented the proposal to import and marketing of the drug Anifrolumab concentrate for solution for infusion 150 mg/ml indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy with local clinical trial waiver.

Systemic lupus erythematosus (SLE), is the most common type of lupus. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. There is no cure for lupus, but medical interventions and lifestyle changes can help control it.

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 type 1 interferon receptor (IFNAR) inhibiting IgG1κ monoclonal antibody indicated in the treatment of adults with moderate to severe systemic lupus erythematosus.

The standard therapy for systemic lupus erythematosus consists of antimalarials like hydroxychloroquine, glucocorticoids like dexamethasone, and disease modifying antirheumatic drugs like methotrexate.

Anifrolumab is an immunoglobulin gamma 1 kappa (IgG1k) monoclonal antibody that selectively binds to subunit 1 of type 1 interferon receptor( INFAR1). This binding of anifrolumab to IFNAR1 halts the activity of the receptor, reducing downstream signalling and gene transcription of inflammatory mediators. Unlike other anti-type 1 interferon (IFN) agents that aim only to neutralize IFN alpha, anifrolumab antagonizes the receptor responsible for cellular signaling induced by IFN alpha, IFN beta, IFN epsilon, IFN kappa, and IFN omega.

At the recent SEC meeting for Analgesic & Rheumatology held on December 14th 2022, the expert panel reviewed the proposal presented by the drug major AstraZeneca to import and market the monoclonal antibody Anifrolumab 150mg/ml concentrate for solution for infusion which is used in the treatment of moderate to severe systemic lupus erythematous.

The committee noted that the firm presented the results of various clinical trials conducted in other countries. The committee also found that the drug is approved in the United States, European Union, Japan, Canada, United Kingdom, Australia etc.

In addition to the above, the expert panel noted that there is no study data available in Indian population. After detailed deliberation, the committee recommended that the firm should conduct clinical trials in the Indian population.

Also Read:CDSCO panel opines Johnson and Johnson to submit details of anticancer drug Teclistamab nod in EU, US

AstraZenecaAnifrolumabsystemic lupus erythematosuscdscosec committee

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.