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Novartis receives EU approval for Lucentis in new indication
Novartis has been granted approval from the European Commission for its drug Lucentis in a new indication.
The therapy has been approved to treat patients with visual impairment due to choroidal neovascularisation associated with causes other than neovascular age-related macular degeneration, or secondary to pathologic myopia.
Results of the pivotal MINERVA study showed that the drug was associated with a significant gain in visual acuity of approximately ten letters at two months, which was maintained for one year.
This makes Lucentis the first and only treatment approved in this indication in the EU, as well as being the only treatment available for a wide range of CNV conditions.
Paul Hudson, chief executive officer of Novartis Pharmaceuticals, said: "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."
Submissions for this indication have also been filed in 11 other countries, including Switzerland, Australia, Indonesia and Brazil.
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