Log in
Log in
Or log in with
GoogleGoogle
Twitter Twitter
Facebook Facebook
Apple Apple     
Sign up
Or log in with
GoogleGoogle
Twitter Twitter
Facebook Facebook
Apple Apple     
  1. Homepage
  2. Equities
  3. Switzerland
  4. Swiss Exchange
  5. Novartis AG
  6. News
  7. Summary
    NOVN   CH0012005267

NOVARTIS AG

(NOVN)
  Report
Delayed Swiss Exchange  -  12:21 2022-09-23 pm EDT
74.36 CHF   -0.92%
09/23NOVARTIS AG : Deutsche Bank gives a Sell rating
MD
09/23NOVARTIS AG : Gets a Sell rating from Barclays
MD
09/23AlphaValue/Baader Europe Lifts Price Target on Novartis, Maintains Add Recommendation
MT
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisionsFunds 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

Novartis : announces European Commission approval of Beovu® for people living with diabetic macular edema

03/31/2022 | 02:16am EDT
  • Diabetic macular edema (DME) is a leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution in the retina and addressing the burden of frequent treatment schedules1,2
  • Approval is based on year one data from the Phase III KESTREL and KITE trials investigating Beovu (brolucizumab) 6 mg versus aflibercept 2 mg in DME patients2
  • In KESTREL and KITE, Beovu was non-inferior to aflibercept in change in best-corrected visual acuity (BCVA) from baseline and showed potential for fluid resolution in numerically more DME patients2
  • KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one2
  • Beovu is approved for the treatment of wet age-related macular degeneration in more than 70 countries, including in the EU

Basel, March 31, 2022 - Novartis today announced that the European Commission (EC) has approved Beovu® (brolucizumab) 6 mg for the treatment of visual impairment due to diabetic macular edema (DME). Today's approval in DME represents the second indication for Beovu granted by the EC, which was first approved for the treatment of wet age-related macular degeneration in 20203. The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway and Liechtenstein.

The EC approval was based on year one data from the Phase III, randomized, double-masked KESTREL and KITE* studies, which met their primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at year one2. In both trials, following the loading phase, over half of patients (55.1% in KESTREL and 50.3% in KITE) in the Beovu 6 mg arm remained on a 12-week dosing interval through year one2. Aflibercept dosing was aligned to the approved EU label in year one of treatment2,4. In aggregate, a numerically lower proportion of patient eyes treated with Beovu had intraretinal fluid, subretinal fluid or both at week 52 versus eyes treated with aflibercept (in KESTREL 60.3% in Beovu arm versus 73.3% in aflibercept arm; in KITE 54.2% versus 72.9%, respectively; testing for statistical significance was not performed)2.

Per the approved prescribing information, following the loading phase of five doses injected six weeks apart, physicians may individualize treatment for DME patients based on their disease activity, as assessed by vision and fluid-related parameters3. In patients without disease activity, physicians should consider 12-week intervals between Beovu treatments; in patients with disease activity, physicians should consider eight-week intervals between treatments3.

"This approval marks a significant milestone for DME patients, many of whom are of working age and struggle with adherence due to the need to manage multiple comorbidities related to diabetes," said Jill Hopkins, SVP and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals. "KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one.* The EC approval of Beovu in DME may thus help address unmet needs."

The most common ocular and non-ocular adverse events (≥5%) at year one in KESTREL and KITE were conjunctival hemorrhage, nasopharyngitis and hypertension2. Intraocular inflammation (IOI) rates in KESTREL were 4.7% for brolucizumab 3 mg (including 1.6% retinal vasculitis), 3.7% for Beovu 6 mg (including 0.5% retinal vasculitis), and 0.5% for aflibercept 2 mg2. IOI rates in KITE were equivalent (1.7%) between the Beovu 6 mg and aflibercept 2 mg arms with no retinal vasculitis reported2. Retinal vascular occlusion was reported in KESTREL for brolucizumab 3 mg (1.1%) and 6 mg (0.5%), and in KITE for brolucizumab and aflibercept (0.6% each)2. The majority of these events were manageable and resolved with routine clinical care2. In KESTREL, the percentage of patients who experienced ≥15 letter loss from baseline at year one was 1.6% for brolucizumab 3 mg, 0% for Beovu 6 mg and 0.5% for aflibercept2. In KITE, the percentage of patients who experienced ≥15 letter loss from baseline at year one was 1.1% for Beovu 6 mg and 1.7% for aflibercept2. Brolucizumab 6 mg is the commercialized dose of Beovu3.

Novartis remains committed to bringing Beovu to the patients who may benefit from this important medicine. Regulatory applications for Beovu in DME are under review by the U.S. Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Discussions with additional health authorities regarding Beovu are ongoing.

*Aflibercept dosing was aligned to the approved EU label in year one of treatment

About the KESTREL and KITE clinical trials
KESTREL and KITE are global, randomized, double-masked, Phase III, two-year studies comparing the safety and efficacy of Beovu and aflibercept in the treatment of patients with visual impairment due to DME5,6.

KESTREL and KITE involved 926 total patients in 36 countries5,6. In the loading phase of both trials, patients in the Beovu arms were treated every six weeks for a total of five doses; patients in the aflibercept arms were treated every four weeks for a total of five doses, in line with its label5,6. In the first year of the study, following the loading phase, patients in the Beovu arms were subsequently treated every 12 weeks, with those demonstrating disease activity moved to dosing every eight weeks5,6. After the loading phase, patients in the aflibercept arms were treated every eight weeks5,6.

About diabetic macular edema (DME)
DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity, eventually leading to blindness1. DME is a leading cause of blindness in adults in developed countries, affecting 12% of patients with type 1 diabetes and 28% of those with type 2 diabetes1.

Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid1. This damage leads to an excess of vascular endothelial growth factor (VEGF)1,7. VEGF is a protein that stimulates the growth of blood vessels1,7. At elevated levels in DME, VEGF stimulates the growth of abnormal, leaky blood vessels1,7. The resulting accumulation of fluid (known as edema) in the macula is a key marker of disease activity and can lead to vision loss1,7. The macula is the area of the retina responsible for sharp, central vision1,7. Early symptoms of DME include blurry or wavy central vision and distorted color perception, although the disease can also progress without symptoms at early stages7,8.

About Beovu (brolucizumab) 6 mg
Beovu (brolucizumab, also known as RTH258) 6 mg is approved for the treatment of wet age-related macular degeneration (AMD) in more than 70 countries, including in the US, EU, UK, Japan, Canada and Australia3,9-12. In March 2022, Beovu was also approved by the European Commission (EC) to treat diabetic macular edema (DME), applying to all 27 European Union member states as well as Iceland, Norway and Liechtenstein. Additional trials, which study the effects of brolucizumab in patients with wet AMD, diabetic macular edema (DME), and proliferative diabetic retinopathy (PDR), are currently ongoing.

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.

*Kite Pharma, Inc. is neither a sponsor of nor associated with Novartis' KITE trial.

Disclaimer
This media update 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," "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 media update, 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 media update 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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update 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 nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact [email protected]

References

  1. Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011;2(6):98-104.
  2. Brown D, Wolf S, Garweg JG, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL & KITE studies. Presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. May 2021.
  3. Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.
  4. Eylea [summary of product characteristics] Berlin, Germany. Bayer AG: 2014.
  5. Data on file. KESTREL clinical trial protocol (CRTH258B2301). Novartis, 2021.
  6. Data on file. KITE clinical trial protocol (CRTH258B2302). Novartis, 2021.
  7. National Eye Institute. Macular Edema. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema. Accessed March 2022.
  8. National Eye Institute. Diabetic Retinopathy. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy. Accessed March 2022.
  9. Beovu [US prescribing information] East Hanover, NJ. Novartis: 2020.
  10. Pharma Japan. National Health Insurance Pricing. Available at: https://pj.jiho.jp/sites/default/files/pj/document/2020/05/New%20Drugs%20to%20Be%20Added%20to%20NHI%20Price%20List%20on%20May%2020_1.pdf. Accessed March 2022.
  11. Canadian Agency for Drugs and Technologies in Health. CADTH Canadian Drug Expert Committee Recommendation. Available at: https://cadth.ca/sites/default/files/cdr/complete/SR0632%20Beovu%20-%20CDEC%20Final%20Recommendation%20%E2%80%93%20May%2025%2C%202020_for%20posting.pdf. Accessed March 2022.
  12. Beovu [prescription medicine decision summary] Australia. Novartis: 2020.

# # #

Novartis Media Relations
E-mail: [email protected]

Neil Henderson
Novartis External Communications
+41 79 3612869
[email protected]

Julie Masow
Novartis US External Communications
+1 862 579 8456
[email protected]
Meghan O'Donnell
Novartis Division Communications
+41 79 797 9102
[email protected]

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: [email protected]

Central North America
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440
Nicole Zinsli-Somm +41 61 324 3809 Alina Levchuk +1 862 778 3372
Isabella Zinck +41 61 324 7188 Parag Mahanti +1 973-876-4912

Disclaimer

Novartis AG published this content on 31 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 March 2022 06:15:07 UTC.


© Publicnow 2022
All news about NOVARTIS AG
09/23NOVARTIS AG : Deutsche Bank gives a Sell rating
MD
09/23NOVARTIS AG : Gets a Sell rating from Barclays
MD
09/23AlphaValue/Baader Europe Lifts Price Target on Novartis, Maintains Add Recommendation
MT
09/23NOVARTIS AG : Credit Suisse keeps a Sell rating
MD
09/23NOVARTIS AG : Goldman Sachs maintains a Buy rating
MD
09/22GLOBAL MARKETS LIVE : Veolia, Meta, Amazon, Salesforce, Target...
MS
09/22SECTOR UPDATE : Health Care Stocks Mixed Premarket Thursday
MT
09/22ETF PREVIEW : ETFs Mixed, Futures Slightly Higher Pre-Bell After Fed Rate Increase, Jobles..
MT
09/22MARKETSCREENER'S WORLD PRESS REVIEW : September 22, 2022
MS
09/22Novartis Says to Adopt 'US-First Mindset' to Become Top-Five Player by 2027
MT
More news
Analyst Recommendations on NOVARTIS AG
More recommendations
Financials (USD)
Sales 2022 52 338 M - -
Net income 2022 9 143 M - -
Net Debt 2022 7 589 M - -
P/E ratio 2022 18,3x
Yield 2022 4,39%
Capitalization 165 B 165 B -
EV / Sales 2022 3,31x
EV / Sales 2023 3,24x
Nbr of Employees 108 000
Free-Float 87,1%
Chart NOVARTIS AG
Duration : Period :
Novartis AG Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends NOVARTIS AG
Short TermMid-TermLong Term
TrendsBearishBearishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 25
Last Close Price 75,81 $
Average target price 92,57 $
Spread / Average Target 22,1%
EPS Revisions
Managers and Directors
Vasant Narasimhan Chief Executive Officer
Harry Werner Kirsch Chief Financial Officer
Hans Jörg Reinhardt Non-Executive Chairman
Shreeram Aradhye Chief Medical Officer
Steffen Lang President-Operations
Sector and Competitors
1st jan.Capi. (M$)
NOVARTIS AG-7.37%165 486
JOHNSON & JOHNSON-2.54%438 337
ELI LILLY AND COMPANY12.54%295 941
ROCHE HOLDING AG-18.41%259 291
ABBVIE INC.5.66%252 944
PFIZER, INC.-25.35%247 392