Lucentis has been recommended for approval for the treatment of retinopathy of prematurity in preterm infants by the European Medicines Agency’s Committee for Medicinal Products for Human Use, Novartis announced in a press release.
If approved, Lucentis (ranibizumab 10 mg/mL) would be the first pharmacological therapy approved for ROP.
“We recognize the importance of investing in clinical programs to secure marketing authorization ensuring safe use of pharmacological therapies in vulnerable pediatric patient populations,” Dirk Sauer, development unit head, Novartis
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