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 Ophthalmology, said in the release. “We are very excited to be one step closer to bringing this transformative treatment to preterm ROP patients across Europe.”
The CHMP opinion will be reviewed by the European Commission, which will deliver a final decision within 3 months.