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

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

December 8, 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].

About MINERVA study trial
The submission was supported by data from the Novartis sponsored MINERVA[5] study, which showed that Lucentis treatment resulted in a significant gain of visual acuity by approximately 10 letters at two months; this gain was maintained to month 12 of the one-year study[1]. Ranibizumab has therefore proven to be effective for the treatment of CNV, regardless of the underlying etiology, with no new safety findings[1].

About Lucentis
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in nAMD and other ocular diseases such as DME and retinal vein occlusion (RVO). Lucentis was specifically designed for the eye, minimizing systemic exposure.

Lucentis is licensed for the treatment of nAMD, and for the treatment of visual impairment due to CNV, DME, BRVO and CRVO. The indication for the treatment of visual impairment due to CNV includes secondary to pathologic myopia (PM) and CNV associated with causes other than nAMD or PM (approved in EMA only).

Lucentis is available in more than 110 countries and has a well-established safety profile supported by a portfolio of 129 sponsored clinical studies in addition to extensive real-world experience. The safety profile of Lucentis has been well established in a clinical development program that has enrolled more than 76,000 patients across indications and has 3.7 million patient-treatment years of exposure since its launch in the United States in 2006. Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.

References
[1] Lai, T et al. Efficacy and safety of ranibizumab 0.5 mg in adult patients with visual impairment due to choroidal neovascularization associated with rare diseases: 12 month results of the MINERVA study. European Society of Retina Specialists (EURETINA) 2016.
[2] American Academy of Ophthalmology. What Are Choroidal Neovascular Membranes? Available at http://www.aao.org/eye-health/diseases/choroidal-neovascular-membranes(link is external). Accessed October 2016.
[3] American Academy of Ophthalmology. Choroidal Neovascular Membranes Symptoms. Available at http://www.aao.org/eye-health/diseases/choroidal-neovascular-membranes-symptoms(link is external). Accessed October 2016.
[4] Cohen S et al. Etiology of choroidal neovascularization in young patients. Ophthalmology 1996; 103: 1241-1244.
[5] ClinicalTrials.gov. Identifier NCT01840410. Available at https://clinicaltrials.gov/ct2/show/study/NCT01840410(link is external). Accessed October 2016.