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Novartis AG. (2/17/20). "Press Release: Novartis Receives EC Approval for Beovu, a Next-generation anti-VEGF Treatment for wet AMD, a Leading Cause of Blindness Worldwide". Basel.

Region Region EU (European Union)
Organisations Organisation Novartis AG (NYSE: NVS)
  Group Novartis (Group)
  Organisation 2 European Commission (EC)
  Group EU (govt)
Products Product Beovu®
  Product 2 phase 3 study
Person Person Tschudin, Marie-France (Novartis 201906– President Novartis Pharmaceuticals joined 2017 before 10y at Celgene)
     


> Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on three-month dosing intervals immediately after the loading phase1

> For the more than 20 million people worldwide who are living with wet AMD, frequent injections are a common reason patients drop off existing treatments2-4

> Approval is based on two head-to-head clinical trials, HAWK and HARRIER, in which Beovu achieved robust vision gains that were non-inferior to aflibercept at year one (primary endpoint)1,5

> Beovu also demonstrated superior fluid resolution versus aflibercept at week 16 and year one (secondary endpoints)1,5


Novartis today announced the European Commission (EC) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints)1,5. Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase1,5. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

“Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease. We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimize treatments for patients based on disease activity,” said Marie-France Tschudin, President Novartis Pharmaceuticals. “With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.”

“Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy,” said Frank Holz, MD, FEBO, FARVO, Professor and Chairman, Department of Ophthalmology, University of Bonn, Germany. “Beovu, with its superior fluid resolution as demonstrated in the HAWK and HARRIER trials, will provide physicians with a new option to treat wet AMD.”

Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision6,7. The disease is a leading cause of severe vision loss and blindness in people over age 65, affecting more than 20 million people worldwide3,4,8. In the EU, an estimated 1.7 million people are affected by wet AMD9. Early symptoms of wet AMD include blurry or wavy vision7. As the disease progresses, patients lose central vision, making it difficult to see objects directly in front of them7.

The EC approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in best corrected visual acuity (BCVA) that were non-inferior to aflibercept at year one (week 48)1,5. Vision gains at year one were maintained at year two1,5.

In fluid-related secondary endpoints, Beovu outperformed aflibercept1,5. Significantly fewer patients had intra-retinal and/or sub-retinal fluid (IRF/SRF), two fluids which may disrupt the normal retinal structure and cause damage to the macula (31% for brolucizumab 6 mg vs. 45% for aflibercept in HAWK; 26% vs. 44%, respectively, in HARRIER at year one)1,5,10. Additionally, Beovu showed superior reductions in central subfield thickness, another indicator of retinal fluid, at week 16 and at year one1,5. Differences seen at year one were maintained at year two1,5. In both trials, 30% fewer patients had signs of disease activity with Beovu versus aflibercept as early as week 1611.

In HAWK and HARRIER, over half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER) at year one1,5. The remaining patients in the study were treated on a two-month dosing interval1,5.

“Today’s approval is a step forward for patients in Europe who have been looking for a new treatment option which may help them maintain their sight — and their independence — for longer,” said Christina Fasser, President, Retina International. “This can really help to alleviate a burden, not only on the patient themselves, but also on those who care for them."

In October 2019, Novartis received approval from the U.S. Food and Drug Administration for Beovu for the treatment of wet AMD12. Beovu received Swissmedic approval in Switzerland13 and Australian TGA approval14 in January 2020, both for the treatment of wet AMD. Novartis is committed to bringing Beovu to patients worldwide, and additional regulatory filings are currently underway in Canada, Japan and Brazil.


About Beovu (brolucizumab)

Beovu (brolucizumab, also known as RTH258) is the most clinically advanced humanized single-chain antibody fragment (scFv)5,15. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics15-17.

The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms16. Beovu is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs5,15. In preclinical studies, Beovu inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction16-18. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema19. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability19.


About the HAWK and HARRIER studies

With more than 1,800 patients across nearly 400 centers worldwide, HAWK (NCT02307682) and HARRIER (NCT02434328) are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 using an innovative q12w/q8w regimen, with a majority of patients on q12w immediately following the loading phase5. Both studies are 96-week prospective, randomized, double-masked multi-center studies and part of the Phase III clinical development of Beovu5. The studies were designed to compare the efficacy and safety of intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in patients with wet AMD5.


About wet age-related macular degeneration

Wet AMD is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America, Europe, Australia and Asia, impacting an estimated 20 million people worldwide3,4,8. Wet AMD occurs when abnormal blood vessels form underneath the macula, the area of the retina responsible for sharp, central vision7,20,21. These blood vessels are fragile and leak fluid, disrupting the normal retinal architecture and ultimately causing damage to the macula7,20,21.

Early symptoms of wet AMD include distorted vision (or metamorphopsia) and difficulties seeing objects clearly22. Prompt diagnosis and intervention are essential21. As the disease progresses, cell damage increases, further reducing vision quality7. This progression can lead to a complete loss of central vision, leaving the patient unable to read, drive or recognize familiar faces and potentially depriving them of their independence7,23. Without treatment, vision can rapidly deteriorate24.


About Novartis in ophthalmology

At Novartis, our mission is to discover new ways to improve and extend people's lives. In ophthalmology, we develop and deliver life-changing medicines and therapies for diseases and conditions from front to back of the eye, enabled by data and transformative technologies. Our ophthalmic solutions reach more than 150M people per year, from premature infants to the elderly.


Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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References

1. Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.

2. Varano M, et al. Current barriers to treatment for wet age-related macular degeneration (wAMD): findings from the wAMD patient and caregiver survey. Clin Ophthalmol. 2015;9:2243–2250.

3. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and met analysis. Lancet Glob Health. 2014;2:106-16.

4. Singer M. Advances in the management of macular degeneration. F1000Prime Rep. 2014;6:29.

5. Dugel P, Koh A, Ogura Y, et al; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.

6. Qazi Y, et al. Mediators of ocular angiogenesis. J. Genet. 2009;88(4):495-515.

7. National Eye Institute. Facts About Age-Related Macular Degeneration. Available at https://nei.nih.gov/health/maculardegen/armd_facts (link is external). Accessed February 2020.

8. Schmidt-Erfurth U, et al. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98:1144-1167.

9. European Society for Retinal Specialists (EURETINA). Retinal Diseases in Europe: Prevalence, Incidence, and Healthcare Needs. Available at: https://www.euretina.org/downloads/EURETINA_Retinal_Diseases.pdf. Accessed February 2020.

10. Arnold J, et al. The role of sub-retinal fluid in determining treatment outcomes in patients with neovascular age-related macular degeneration--a phase IV randomised clinical trial with ranibizumab: the FLUID study. BMC Ophthalmol. 2016;143(4):679-680.

11. Data on file. RTH258 Core Data Sheet. Novartis; 2019.

12. Beovu [US prescribing information] East Hanover, NJ. Novartis: 2019.

13. Beovu [Swissmedic prescribing information] Switzerland. Novartis: 2020.

14. Beovu [prescription medicine decision summary] Australia. Novartis: 2020.

15. Nimz EL, et al. Intraocular and systemic pharmacokinetics of brolucizumab (RTH258) in nonhuman primates. The Association for Research in Vision and Ophthalmology (ARVO) annual meeting. 2016. Abstract 4996.

16. Escher D, et al. Single-chain antibody fragments in ophthalmology. Oral presentation at EURETINA congress. 2015. Abstract.

17. Gaudreault J, et al. Preclinical pharmacology and safety of ESBA1008, a single-chain antibody fragment, investigated as potential treatment for age related macular degeneration. ARVO Annual Meeting abstract. Invest Ophthalmol Vis Sci 2012;53:3025. http://iovs.arvojournals.org/article.aspx?articleid=2354604 (link is external). Accessed February 2020.

18. Tietz J, et al. Affinity and Potency of RTH258 (ESBA1008), a Novel Inhibitor of Vascular Endothelial Growth Factor A for the Treatment of Retinal Disorders. IOVS. 2015; 56(7):1501.

19. Kim R. Introduction, mechanism of action and rationale for anti-vascular endothelial growth factor drugs in age-related macular degeneration. Indian J Ophthalmol. 2007;55(6):413-415.

20. World Health Organization. Priority eye diseases: Age-related macular degeneration. Available at http://www.who.int/blindness/causes/priority/en/index7.html (link is external). Accessed February 2020.

21. NHS Choices. Macular Degeneration. Available at http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx (link is external). Accessed February 2020.

22. Healthline. What is metamorphopsia? Available at https://www.healthline.com/health/metamorphopsia (link is external). Accessed February 2020.

23. Mitchell J, Bradley C. Quality of life in age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97.

24. van Lookeren Campagne M, et al. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014; 232(2):151-64. doi: 10.1002/path.4266.


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