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Novartis: CHMP Adopts Positive Opinion On Approval Of Lucentis - Quick Facts

Novartis (NVS) said the Committee of the European Medicines Agency has recommended approval of Lucentis for the treatment of preterm infants with retinopathy of prematurity. If approved, Lucentis (ranibizumab) will be the first and only pharmacological therapy for this patient population.

The CHMP adopted the positive opinion based on the landmark Phase III RAINBOW trial, which showed that Lucentis (ranibizumab) is an efficacious and safe treatment for infants with retinopathy of prematurity. The European Commission is expected to deliver its final decision within three months.

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