CDSCO panel opines Sun Pharma to submit more safety data of Ranibizumab Solution for Injection
New Delhi: Responding to the proposal presented by the pharmaceutical major Sun Pharma for approval of additional indications for the already approved drug product of Ranibizumab solution for injection 10 mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit more safety data for consideration of approval of the additional indications.
This came after the drug major Sun Pharma presented their proposal for approval of additional indications for the already approved drug product of Ranibizumab solution for injection 10 mg/ml.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes angiogenesis throughout the body and in the eye.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that binds human vascular endothelial growth factor A (VEGF-A) to prevent it from binding its receptors, thereby suppressing neovascularization.
Ranibizumab injection for intravitreal use is indicated to treat Neovascular (wet) Age-related Macular Degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
At the recent SEC meeting for Ophthalmology held on 20 September 2023, the expert panel reviewed the proposal presented by the pharma major Sun Pharma for the approval of additional indications or the already approved drug product of Ranibizumab solution for injection 10 mg/ml.
The committee noted that the firm has not yet launched the drug product in the market.
After detailed deliberation, the committee recommended that the firm should submit more safety data for consideration of approval of the additional indications.
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