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Press Release: Novartis receives positive CHMP opinion for Beovu(R) (brolucizumab) for the treatment of wet AMD

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*DJ Novartis receives positive CHMP opinion for Beovu(R) (brolucizumab) for the treatment of wet AMD

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December 13, 2019 07:03 ET ( 12:03 GMT)



In two head-to-head clinical trials, patients on Beovu achieved vision
gains that were non-inferior to aflibercept at year one1

In a pre-specified secondary endpoint, fewer patients had intra-retinal
fluid and/or sub-retinal fluid at week 16 and year one with Beovu1

In a key pre-specified secondary endpoint, over half of Beovu 6mg
patients (56% in HAWK and 51% in HARRIER) were maintained on three-month
dosing intervals immediately after the loading phase through year one1

Frequent injections are a common reason patients drop off treatment for
wet AMD, a leading cause of blindness that affects more than 20M people
worldwide2-4


Basel, December 13, 2019 Novartis today announced that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion for Beovu(R) (brolucizumab 6
mg), also known as RTH258, an investigational product for the treatment
of wet age-related macular degeneration (AMD).

"Today's CHMP opinion brings us another step closer to providing wet AMD
patients in Europe with a new treatment option," said Nikos Tripodis,
Worldwide Franchise Head, Novartis Ophthalmology. "At Novartis, we
remain committed to reimagining treatments for patients suffering from
wet AMD, a leading cause of blindness worldwide."

Wet AMD is caused by uncontrolled VEGF, a protein that promotes abnormal
blood vessel formation underneath the macula, the area of the retina
responsible for sharp, central vision(5,6) . These blood vessels are
fragile and leak fluid, disrupting the normal retinal architecture and
ultimately causing damage to the macula(5,6) . By inhibiting VEGF, Beovu
is designed to suppress the growth of abnormal blood vessels and the
potential for fluid leakage into the retina(1) .

The positive CHMP opinion is based on findings from the Phase III,
global, head-to-head HAWK and HARRIER clinical trials, in which Beovu
demonstrated non-inferiority versus aflibercept in mean change in
best-corrected visual acuity from baseline to year one(1) . In both
trials, approximately 30% of patients treated with Beovu gained at least
15 letters at year one(1) .*

In pre-specified secondary endpoints, fewer patients treated with Beovu
6mg versus aflibercept had intra-retinal and/or sub-retinal fluid at
week 16 (35% fewer patients in both HAWK and HARRIER) and at year one
(30% fewer patients in HAWK and 41% fewer patients in HARRIER)(1) .
Significant reductions in central subfield thickness were also seen with
Beovu(1) .

Additionally, over half (56% in HAWK and 51% in HARRIER) of patients
treated with Beovu 6mg maintained a three-month dosing interval
immediately after the loading phase through year one(1) . Beovu patients
who started on three-month dosing intervals after the loading phase had
an 85% (HAWK) and 82% (HARRIER) probability of remaining on this
interval through year one(1) .

Beovu exhibited an overall safety profile comparable to aflibercept. The
most common adverse events (>=5% of patients) with Beovu were vision
blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye
pain(1) .

In October 2019, Novartis received the first, and so far the only,
approval for Beovu from the U.S. Food and Drug Administration in the
treatment of wet AMD. The European Commission will consider the CHMP
opinion as it makes its final decision on the marketing authorization
for Beovu. The decision is expected within three months.

*Patients receiving Beovu showed a numerical improvement in treatment
versus aflibercept, but the p values did not result in statistical
significance.

About Beovu (brolucizumab)

Beovu (brolucizumab, also known as RTH258) is the most clinically
advanced humanized single-chain antibody fragment (scFv)(1,7) .
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(7-9) .

The proprietary innovative structure results in a small molecule (26
kDa) with potent inhibition of, and high affinity to, all VEGF-A
isoforms(8) . Beovu is engineered to deliver the highest concentration
of drug, providing more active binding agents than other anti-VEGFs(1,7)
. In preclinical studies, Beovu inhibited activation of VEGF receptors
through prevention of the ligand-receptor interaction(8-10) . Increased
signaling through the VEGF pathway is associated with pathologic ocular
angiogenesis and retinal edema(5) . Inhibition of the VEGF pathway has
been shown to inhibit the growth of neovascular lesions and suppress
endothelial cell proliferation and vascular permeability(5) .

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(1) . Both studies are 96-week prospective, randomized,
double-masked multi-center studies and part of the Phase III clinical
development of Beovu(1) . 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(1) .

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(3,4,11) . Wet
AMD occurs when abnormal blood vessels form underneath the macula, the
area of the retina responsible for sharp, central vision(6,12,13) .
These blood vessels are fragile and leak fluid, disrupting the normal
retinal architecture and ultimately causing damage to the
macula(6,12,13) .

Early symptoms of wet AMD include distorted vision (or metamorphopsia)
and difficulties seeing objects clearly(14) . Prompt diagnosis and
intervention are essential(13) . As the disease progresses, cell damage
increases, further reducing vision quality(6) . 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(6,15) . Without treatment, vision can rapidly
deteriorate(16) .

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 that can generally be identified by words such as "positive CHMP
opinion," "investigational," "another step closer," "committed,"
"potential," "so far," "will," "expected," "within three months," "can,"
"potentially," "mission," or similar terms, or by express or implied
discussions regarding potential marketing approvals, new indications or
labeling for Beovu, or regarding potential future revenues from Beovu.
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 Beovu
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 Beovu will be commercially successful in the future.
In particular, our expectations regarding Beovu could be affected by,
among other things, regulatory actions or delays or government
regulation generally; the uncertainties inherent in research and
development, including clinical trial results and additional analysis of
existing clinical data; 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 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

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December 13, 2019 07:03 ET ( 12:03 GMT)
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