Novartis' Lucentis® received EU approval in new indication - Lucentis the only treatment available for a wide range of CNV conditions

Novartis International AG / Novartis' Lucentis® received EU approval in new indication - Lucentis the only treatment available for a wide range of CNV conditions . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• The European Commission approved Lucentis to treat patients for visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD) or secondary to pathologic myopia (PM)
   

Results of the pivotal MINERVA[5] study showed a significant gain in visual acuity of approximately 10 letters at two months, which was maintained for one year[1]
 

Lucentis (ranibizumab) is the first and only treatment approved in this indication in the EU, and the only treatment available for a wide range of CNV conditions

Basel, December 7, 2016 - Novartis today announced that the European Commission (EC) has granted an additional indication for 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.

About CNV
CNV is an ocular condition caused by the growth of abnormal blood vessels below the retina, which cause disruption to vision[2]. The condition can occur rapidly, and is a major cause of vision loss, causing symptoms including visual distortion, color disturbances, partial loss of vison or a blindspot within the visual field[3]. CNV is most commonly associated with neovascular ("wet") age-related macular degeneration and pathologic myopia, but it can also occur with many other conditions including uveitis, central serous chorioretinopathy, angioid streaks, trauma, retinal or macular dystrophies, and with no apparent cause (idiopathic CNV)[4].