Lucentis Recommended by CHMP for EU Approval in Sixth Indication for the Treatment of Visually Impaired Patients
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD) or myopic CNV. If approved by the European Commission (EC), ranibizumab would be the first retinal treatment approved for these conditions, addressing an important unmet medical need.
“This important milestone reinforces our long-standing commitment to provide treatment solutions that improve outcomes for visually impaired patients in Europe,” Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis, said in a company news release. “Lucentis has already transformed the management of a number of ocular conditions, and we are hopeful that these additional patient groups affected by CNV will benefit from this treatment.”
The submission was supported by data from the Novartis-sponsored study trial MINERVA5, which showed that ranibizumab treatment resulted in a significant gain of visual acuity by approximately 10 letters at 2 months; this gain was maintained to month 12 of the one-year study. Ranibizumab has therefore proven to be effective for the treatment of CNV, regardless of the underlying etiology, with no new safety findings.
The EC typically adheres to the recommendation of the CHMP and delivers its final decision within 2 to 3 months. The decision will be applicable to all 28 European member states, including Iceland and Norway.
If approved, ranibizumab would be registered for use in six indications in visually impaired patients in Europe (nAMD, visual impairment due to diabetic macular edema (DME), branch and central retinal vein occlusion (BRVO, CRVO), and choroidal neovascularization (CNV) secondary to pathologic myopia (PM)).
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