Novartis Gets CDSCO Panel Nod To Study Ianalumab
New Delhi: In a significant development, drug major Novartis has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct Phase III clinical trial of Ianalumab, an investigtional anti-BAFF receptor monoclonal antibody (mAb) from Novartis.
However, the nod is subjected to condition that the volume of blood to be drawn at each time of sample collection and the frequency of sample collection during the study should be mentioned in protocol and Informed consent document.
This came after the drug maker Novartis presented the Phase III clinical trial protocol no CVAY736K12301 before the committee, in light of the earlier SEC recommendation dated 19/07/2022.
The Medical Dialogues Team had reported earlier that the Subject Expert Committee (SEC) committee had rejected Novartis Healthcare's Phase III clinical trial protocol for monoclonal antibody Ianalumab at the 105th SEC meeting for Cardiovascular & Renal, citing that the clinical trial protocol missed some inclusion/exclusion criteria.
Ianalumab (VAY736) was designed to target the BAFF receptor and competitively inhibit binding of BAFF ligand, and to thereby block BAFF receptor-mediated signalling and the downstream survival pathway in B cells. In addition, it was engineered (by defucosylating carbohydrate modifications on the Fc chain) to enhance antibody-dependent cellular cytotoxicity (ADCC) so as to maximally deplete circulating B cells. Pro-B and pre-B cells are BAFF receptor negative so are not directly affected by ianalumab. Ianalumab targets the receptor, which is in contrast to other BAFF agents which target the ligand (e.g. the approved antibody belimumab, tibulizumab, tabalumab, and the BAFF ligand-sequestering peptides blisibimod and atacicept)
It is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjogren's syndrome, and systemic lupus erythematosus, lupus Nephritis.
Lupus nephritis is a type of kidney disease caused by systemic lupus erythematosus. Lupus is an autoimmune disease link—a disorder in which the body's immune system attacks the body's own cells and organs. Kidney disease caused by lupus may get worse over time and lead to kidney failure.
At the recent SEC meeting for Cardiovascular and Renal held on 11th August 2022,the expert panel reviewed the protocol of a monoconal antibody Ianalumab presented by the drug major Novartis.
