Lupin gets CDSCO panel nod to study Ranibizumab
The drug major Lupin has got the green signal from the Subject Expert Committee (SEC) from the Central Drug Standard Control Organisation (CDSCO) to study the monoclonal antibody Ranibizumab used to treat neovascular age‐related macular degeneration.
This came after the firm presented its proposal for a grant of permission to conduct a clinical trial titled “A randomized, open-label study to compare pharmacokinetics and safety of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age‐related macular degeneration” as per protocol No. LRP/LUBT010/2022/001; version 1.0 Date: 10.08.2022.”
Neovascular age‐related macular degeneration (AMD) is an advanced form of macular degeneration that historically has accounted for the majority of vision loss related to AMD. The presence of choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.
Ranibizumab is a recombinant humanized monoclonal antibody and VEGF-A antagonist used for the management of macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
Ranibizumab binds human vascular endothelial growth factor A (VEGF-A) to prevent it binding its receptors, thereby suppressing neovascularization. The mechanism of action of ranibizumab is similar to other VEGF-targeting therapies.
Ranibizumab was initially approved by the FDA in 2006 and by the European Commission (EC) in 2007. It is marketed under the brand names LUCENTIS and SUSVIMO.
BYOOVIZ, a biosimilar of LUCENTIS, was approved by Health Canada in March 2022, making it the first and only biosimilar drug of ranibizumab available in Canada.
At the recent SEC meeting for Ophthalmology held on 22nd February 2023, the expert panel reviewed the proposal presented by the drug major Lupin for conducting the clinical trial titled “A randomized, open-label study to compare pharmacokinetics and safety of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age‐related macular degeneration” as per protocol No. LRP/LUBT010/2022/001; version 1.0 Date: 10.08.2022.
After detailed deliberation, the committee recommended the grant of permission to conduct the study as per the presented protocol.