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Novartis' Lucentis Receive EU's CHMP Positive Opinion for Retinopathy of Prematurity in Preterm Infan

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Novartis' Lucentis Receive EU's CHMP Positive Opinion for Retinopathy of Prematurity in Preterm Infan

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  • The EMA’s CHMP has recommended the approval of Lucentis (ranibizumab- 10 mg/ml) for the treatment of ROP in preterm infants with EC’s anticipated decision within three months
  • The submission is based on P-III RAINBOW study results demonstrating Lucentis is safe & well tolerated in infants with ROP. Post-EU approval- Lucentis (0.2 mg) will be indicated for the treatment of preterm infants with zone I (stage 1+- 2+- 3 or 3+)- zone II (stage 3+) or AP-ROP disease
  • Lucentis is an anti-VEGF therapy- act by destroying the tissue in the eye responsible for the elevation of VEGF and developed by Genentech & Novartis with its US rights belonging to Genentech and ROW rights to Novartis

Click here to­ read full press release/ article | Ref: Novartis | Image: Chicago Tribune


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