TIDMNOVN
-- In two head-to-head clinical trials, patients on Beovu (brolucizumab)
achieved vision gains that were non-inferior to aflibercept at year one
with longer treatment intervals in a majority of patients[1],[2]
-- Beovu demonstrated greater reductions in central subfield thickness (CST,
a key indicator of fluid in the retina) as early as week 16 and at one
year versus aflibercept[2]
-- Beovu is the only anti-VEGF in wet AMD recommended to maintain eligible
patients on up to three-month dosing intervals immediately after the
loading phase with no compromise in efficacy[1],[2]
-- In both clinical trials, at year one over half of patients were
maintained on the three-month dosing interval (56% in HAWK and 51% in
HARRIER)[1],[2]
-- Frequent injection intervals are a common reason patients drop off
treatment for wet age-related macular degeneration (AMD), a leading cause
of blindness, affecting more than 20M people worldwide[3]-[5]
Basel, October 8, 2019 -- Novartis today announced that the U.S. Food
and Drug Administration (FDA) approved Beovu(R) (brolucizumab) injection,
also known as RTH258 for the treatment of wet age-related macular
degeneration (AMD)[1]. Beovu is the first FDA approved anti-VEGF to
offer both greater fluid resolution versus aflibercept and the ability
to maintain eligible wet AMD patients on a three-month dosing interval
immediately after a three-month loading phase[1] with uncompromised
efficacy.
"Beovu meets our goals in clinical practice for treating wet AMD:
improving vision and drying retinal fluid," said Dr. Pravin U. Dugel,
Managing Partner, Retinal Consultants of Arizona; Clinical Professor,
Roski Eye Institute, Keck School of Medicine, University of Southern
California; and principal investigator of the HAWK clinical trial. "With
Beovu, greater fluid reduction was demonstrated through larger decreases
in retinal thickness and a higher proportion of patients with drier
retinas. Coupled with the potential to treat patients with quarterly
injections, this approval may change the way we approach the treatment
of wet AMD."
The approval of Beovu was based on findings from the Phase III HAWK and
HARRIER clinical trials, in which Beovu demonstrated non-inferiority
versus aflibercept in mean change in best-corrected visual acuity (BCVA)
at year one (week 48)[1],[2].
In both clinical trials, approximately 30% of patients gained at least
15 letters at year one[1],[2]. In HAWK and HARRIER, Beovu showed greater
reduction in central subfield thickness (CST) as early as week 16 and at
year one, and fewer patients had intra-retinal (IRF) and/or sub-retinal
fluid (SRF)[2]. Retinal fluid is a key marker of disease activity[6].
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 vision[7],[8]. Fluid that leaks out of these abnormal blood
vessels disrupts the normal retinal structure and ultimately damages the
macula[8]-[10]. The Beovu molecule is engineered to deliver the highest
concentration of drug, providing more active binding agents than other
anti-VEGFs[2]. By inhibiting VEGF, Beovu suppresses the growth of
abnormal blood vessels and the potential for fluid leakage into the
retina[2].
"The approval of Beovu delivers on the Novartis commitment to
reimagining treatments for patients suffering from serious visual
impairment," said Marie-France Tschudin, President, Novartis
Pharmaceuticals. "The product labels of existing treatments state that
they are not as effective when dosed every 12 weeks. Beovu is the first
to offer less frequent dosing in the first year of therapy while
maintaining its effectiveness. This gives more time for wet AMD patients
to focus on what's important in their lives."
In HAWK and HARRIER, eligible patients could be maintained on a
three-month dosing interval immediately after the loading phase[1],[2].
At year one, over half of patients were maintained on the three-month
dosing interval (56% in HAWK and 51% in HARRIER)[1],[2]. The remaining
patients in the study were treated on a two-month dosing schedule[1],
[2].
Beovu exhibited an overall safety profile comparable to aflibercept.
Beovu is contraindicated in patients with ocular or periocular
infections, active intraocular inflammation or with known
hypersensitivity to brolucizumab or any of the excipients in Beovu[1].
Hypersensitivity reactions may manifest as rash, pruritus, urticaria,
erythema or severe intraocular inflammation[1].
The most common adverse events (>=5% of patients) with Beovu were vision
blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye
pain[1],[2].
Wet AMD distorts central vision and ultimately causes blindness and loss
of independence[11],[12]. Estimates suggest that in 2020, 1.75 million
people in the U.S. will be living with wet AMD[13]-[15], making it a
growing public health concern. Early symptoms of wet AMD include blurry
or wavy vision[8]. As the disease progresses, patients lose central
vision so it becomes difficult to see objects directly in front of
them[8].
"As sight disappears, so does a person's connection to the world," said
Dawn Prall, Founder and Executive Director, The Support Sight
Foundation. "We welcome a new treatment that helps maintain vision and
has the potential for quarterly treatments, which can reduce the burden
on patients and their caregivers and help people with wet AMD keep doing
what they love with the people they love."
With this approval, Novartis is offering BEOVU Your Way(TM) in the U.S.
This program provides personalized, one-on-one support for patients and
caregivers, with access to a care specialist committed to understanding
patients' unique needs and preferences. Novartis is proud to be
partnering with patient advocacy organizations to deliver educational
materials for patients and caregivers, with the goal of empowering wet
AMD patients to live safely and independently.
About Beovu (brolucizumab)
Beovu (brolucizumab) is the most clinically advanced humanized
single-chain antibody fragment (scFv)[2],[16]. 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 characteristics[16]-[18].
The proprietary innovative structure results in a small molecule (26
kDa) with potent inhibition of, and high affinity to, all VEGF-A
isoforms[17]. Beovu is engineered to deliver the highest concentration
of drug, providing more active binding agents than other anti-VEGFs[2],
[16]. In preclinical studies, Beovu inhibited activation of VEGF
receptors through prevention of the ligand-receptor
interaction[17]-[19]. Increased signaling through the VEGF pathway is
associated with pathologic ocular angiogenesis and retinal edema[20].
Inhibition of the VEGF pathway has been shown to inhibit the growth of
neovascular lesions and suppress endothelial cell proliferation and
vascular permeability[20].
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
phase[2]. Both studies are 96-week prospective, randomized,
double-masked multi-center studies and part of the Phase III clinical
development of Beovu[2]. 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 AMD[2].
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 worldwide[4],[5],[11]. It
is estimated that 1.75 million people in the U.S. will be living with
wet AMD in 2020[13]-[15]. Wet AMD occurs when abnormal blood vessels
form underneath the macula, the area of the retina responsible for sharp,
central vision[8]-[10]. These blood vessels are fragile and leak fluid,
disrupting the normal retinal architecture and ultimately causing damage
to the macula[8]-[10].
Early symptoms of wet AMD include distorted vision (or metamorphopsia)
and difficulties seeing objects clearly[8],[21]. Prompt diagnosis and
intervention are essential[10]. As the disease progresses, cell damage
increases, further reducing vision quality[8]. 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 independence[8],[12]. Without treatment, vision can rapidly
deteriorate[22].
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," "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 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
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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
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globally and we are finding innovative ways to expand access to our
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References
[1] BEOVU [prescribing information] East Hanover, NJ.
Novartis: 2019.
[2] Dugel P, et al. HAWK and HARRIER: Phase 3, multicenter,
randomized, double-masked trials of brolucizumab for neovascular
age-related macular degeneration [published online ahead of print].
Ophthalmology. 2019.
[3] 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.
[4] 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.
[5] Singer M. Advances in the management of macular
degeneration. F1000Prime Rep. 2014;6:29.
[6] 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.
[7] Qazi Y, et al. Mediators of ocular angiogenesis. J.
Genet. 2009;88(4):495-515.
[8] National Eye Institute. Facts About Age-Related Macular
Degeneration. Available at
https://nei.nih.gov/health/maculardegen/armd_facts (link is external).
Accessed September 2019.
[9] 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 September 2019.
[10] NHS Choices. Macular Degeneration. Available at
http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx
(link is external). Accessed September 2019.
[11] 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.
[12] Mitchell J, Bradley C. Quality of life in age-related
macular degeneration: a review of the literature. Health Qual Life
Outcomes. 2006;4:97.
[13] Friedman DS, O'Colmain BJ, Munoz B, et al. Prevalence of
age-related macular degeneration in the United States. Arch Ophthalmol.
2004;122(4):564-72.
[14] Klein R, Chou CF, Klein BE, Zhang X, Meuer SM, Saaddine
JB. Prevalence of age-related macular degeneration in the U.S.
population. Arch Ophthalmol. 2011;129(1):75-80.
[15] American Academy of Ophthalmology. Age-related macular
degeneration preferred practice patterns. Available at:
https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015
(link is external). Accessed September 2019.
[16] 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.
[17] Escher D, et al. Single-chain antibody fragments in
ophthalmology. Oral presentation at EURETINA congress. 2015. Abstract.
[18] 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 September 2019.
[19] 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.
[20] 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.
[21] Healthline. What is metamorphopsia? Available at
https://www.healthline.com/health/metamorphopsia (link is external).
Accessed September 2019.
[22] 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.
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Antonio Ligi Amy Wolf
Novartis External Communications Global Head, Ophthalmology Communications
+41 61 324 1374 (direct) +41 61 696 5894 (direct)
antonio.ligi@novartis.com +41 79 576 0723 (mobile)
Eric Althoff amy.wolf@novartis.com
Novartis US External Communications
+1 646 438 4335
eric.althoff@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
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(END) Dow Jones Newswires
October 08, 2019 01:30 ET (05:30 GMT)
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