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.
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.
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.
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