CDSCO Panel approves Intas Ranibizumab for new indication: retinopathy of pre maturity in preterm infants

New Delhi: Considering the fact that the target subjects are infants, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved Intas pharma’s Ranibizumab for the new indication, retinopathy of pre maturity in preterm infants.

The approval is subjected to the condition that the firm should conduct Phase IV study in target sub-group population after getting the protocol approved and submit the clinical trial data to CDSCO within 1 year of approval for continued marketing of the said indication.

This came after in line with the proposal presented by the drug-maker Intas Pharma for approval of new indication (retinopathy of pre maturity in preterm infants) for Ranibizumab.
In addition, the firm also presented the PSUR data generated with the drug since marketing.

Retinopathy of prematurity (ROP) is an eye disorder caused by abnormal blood vessel growth in the light sensitive part of the eyes (retina) of premature infants. ROP generally affects infants born before week 31 of pregnancy and weighing 2.75 pounds (about 1,250 grams) or less at birth.

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration.

Ranibizumab is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration. The development of ranibizumab first began after bevacizumab, another anti-VEGF anticancer drug, was discovered to inhibit neovascularization and used in the off-label treatment of neovascular age-related macular degeneration for intravenous injection. In order to improve drug delivery to the target organ, ranibizumab is available for intravitreal use.

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.

Ranibizumab injection for intravitreal use via ocular implant is used to treat Neovascular (Wet) Age-related Macular Degeneration (AMD) in patients who have responded to at least two intravitreal injections of a VEGF inhibitor.

At the recent SEC meeting for Ophthalmology held on 25th May 2022, the expert panel reviewed the proposal presented by pharma major Intas for approval of new indication (retinopathy of pre maturity in preterm infants) for Ranibizumab.

After detailed deliberation and considering the fact that the target subjects are infants, the committee recommended approval of the new indication with a condition that the firm should conduct a Phase IV study on the target sub-group population after getting the protocol approved and submit the clinical trial data to CDSCO within 1 year of approval for continued marketing of the said indication.

Accordingly, the firm is directed to submit a protocol for the conduct of a Phase IV clinical trial within 3 months of said indication approval.

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