Novartis' Lucentis receives EU approval in new indication

Novartis

7 December 2016 - The European Commission approved Lucentis to treat patients for visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration or secondary to pathologic myopia.

Novartis today announced that the European Commission has granted an additional indication for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration, or secondary to pathologic myopia. With this approval, Lucentis is the first retinal treatment approved for these conditions, addressing an important unmet medical need.

The approval is applicable to all 28 European member states, as well as Iceland, Liechtenstein and Norway. It was based on the positive opinion from the CHMP, adopted in October 2016. Following this approval, Lucentis covers six indications in Europe.

Submissions for this indication have been filed in 11 other countries, including Switzerland, Australia, Indonesia and Brazil.

Read Novartis press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe