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Novartis' Lucentis Gets EU Approval In New Indication - Quick Facts

Novartis (NVS) said Wednesday that the European Commission has granted an additional indication for Lucentis or ranibizumab to treat patients with visual impairment due to choroidal neovascularization or CNV associated with causes other than neovascular age-related macular degeneration or nAMD, or secondary to pathologic myopia or PM.

With this approval, Lucentis is the first retinal treatment approved for these conditions, addressing an important unmet medical need, the company said.

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 Committee for Medicinal Products for Human Use, 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.

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