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10 Dec 2016

Novartis' Lucentis received EU approval in new indication

Lucentis the only treatment available for a wide range of CNV conditions.

The European Commission (EC) has granted an additional indication for Novartis' 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 secondary to pathologic myopia (PM). With this approval, Lucentis is the first retinal treatment approved for these conditions, addressing an important unmet medical need.

"This confirms Lucentis as standard of care in diseases of the retina," said Paul Hudson, CEO Novartis Pharmaceuticals. "With this approval, Lucentis is the only treatment available for a wide range of CNV conditions. We are dedicated to bringing new innovations to the market, as we are aware that there is still high unmet medical need for patients with retinal diseases."

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 (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.

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