Lucentis® recommended by CHMP for EU approval in sixth indication for the treatment of visually impaired patients
- Recommendation received to treat patients for visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD) or myopic CNV
- Positive opinion means that if approved, Lucentis (ranibizumab) would be the first treatment for use within specific indication in the EU
- CHMP opinion based on a pivotal study showing a significant gain in visual acuity of approximately 10 letters at two months, which was maintained for one year1
Basel, October 14, 2016 – Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion 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 myopic CNV. If approved by the European Commission (EC), ranibizumab would be the first retinal treatment approved for these conditions, addressing an important unmet medical need.
“This important milestone reinforces our long-standing commitment to provide treatment solutions that improve outcomes for visually impaired patients in Europe,” said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “Lucentis has already transformed the management of a number of ocular conditions, and we are hopeful that these additional patient groups affected by CNV will benefit from this treatment.”
CNV is an ocular condition caused by the growth of abnormal blood vessels below the retina, which cause disruption to vision2. 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 field3. 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 and retinal or macular dystrophies4.
The submission was supported by data from the Novartis-sponsored study trial MINERVA5, which showed that ranibizumab 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 study1. Ranibizumab has therefore proven to be effective for the treatment of CNV, regardless of the underlying etiology, with no new safety findings1.
The EC typically adheres to the recommendation of the CHMP and delivers its final decision within two to three months. The decision will be applicable to all 28 European member states, including Iceland and Norway.
If approved, ranibizumab would be registered for use in six indications in visually impaired patients in Europe (nAMD, visual impairment due to diabetic macular edema (DME), branch and central retinal vein occlusion (BRVO, CRVO), and choroidal neovascularization (CNV) secondary to pathologic myopia (PM)).
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 DME, BRVO, CRVO and CNV secondary to pathologic myopia in more than 110 countries.
Lucentis 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.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as “recommended,” “positive opinion,” “would,” “commitment,” “hopeful,” “will,” “recommendation,” or similar terms, or by express or implied discussions regarding potential new indications or labeling for Lucentis, or regarding potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Lucentis will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Lucentis will be commercially successful in the future. In particular, management’s expectations regarding Lucentis could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
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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. 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. 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. Accessed October 2016.