EMA's CHMP recommends a change in authorisation for Lucentis (ranibizumab) in choroidal neovascularisation- Novartis

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lucentis (ranibizumab), from Novartis Europharm. The CHMP adopted an extension to an existing indication as follows: In the EU, Lucentis should be indicated in adults for: 1 The treatment of neovascular (wet) age-related macular degeneration (AMD) 2 The treatment of visual impairment due to choroidal neovascularisation (CNV) 3 The treatment of visual impairment due to diabetic macular oedema (DME) 4 The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

Comment: in 2013 the EU granted Novartis an indication for Lucentis to treat patients with visual impairment due to Choroidal Neovascularization (CNV) secondary to pathologic myopia (myopic CNV). The recommendation is for it to be modified as above.