TARRYTOWN, N.Y., May 13, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the U.S. Food and Drug Administration (FDA) has approved
EYLEA® (aflibercept) Injection to treat all stages of
diabetic retinopathy (DR), and thereby reduce the risk of
blindness.
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"Millions of people have been robbed of their vision due to the
progression of diabetic retinopathy," said David Brown, M.D., F.A.C.S., an investigator for
the PANORAMA trial and Director of Research at Retina Consultants
of Houston. "The prevention of
worsening diabetic retinopathy with EYLEA provides a compelling
rationale for early treatment of patients with this disease,
particularly since eyes dosed with EYLEA as infrequently as every
16 weeks showed significant improvements in the pivotal PANORAMA
trial."
Approximately eight million people live with DR, a complication
of diabetes characterized by damage to the blood vessels in the
retina. The disease generally starts as non-proliferative diabetic
retinopathy (NPDR) and often has no warning signs or symptoms. Over
time, NPDR often progresses to proliferative diabetic retinopathy
(PDR), a stage in which abnormal blood vessels grow on the surface
of the retina and into the vitreous cavity, potentially causing
severe vision loss.
"With today's FDA approval, EYLEA has once again set a high bar
for the treatment of diabetic eye diseases. The PANORAMA trial
showed that by one year, 20% of untreated patients developed
proliferative diabetic eye disease, and EYLEA reduced this risk by
85% to 88% when administered using an every 16-week or eight-week
dosing regimen, respectively," said George
D. Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "In fact, 80% of patients who received the
EYLEA eight-week dosing regimen had significant improvement in
their diabetic retinopathy."
EYLEA is the only vascular endothelial growth factor (VEGF)
inhibitor approved with two dosing options for DR, allowing doctors
to customize treatment to their patients' needs. In DR, EYLEA may
be dosed every eight weeks following five initial monthly
injections, or every four weeks.
About the PANORAMA trial
The FDA approval of EYLEA as a treatment for DR was based on
six-month and one-year results from PANORAMA, a randomized,
multi-center, controlled Phase 3 trial that enrolled 402 patients
and was designed to investigate EYLEA for the improvement of
moderately severe to severe NPDR without diabetic macular edema
(DME), compared to sham injection. PANORAMA is the first
prospective trial to study whether an anti-VEGF can also help
prevent worsening disease in patients with NPDR without
DME.
Details on trial design included:
- Three treatment arms – An observational sham injection
group and two EYLEA treatment groups. EYLEA was dosed every eight
weeks (following five initial monthly doses) or every 16 weeks
(following three initial monthly doses and one eight-week
interval).
- Primary endpoint – The primary endpoint was the
proportion of patients who experienced a two-step or greater
improvement in the diabetic retinopathy severity scale (DRSS) from
baseline for the combined EYLEA treatment groups at week 24, and
for each EYLEA treatment group separately (every eight-week group
and every 16-week group) at week 52. The DRSS is a systematic
grading scale to assess DR severity based on photographs of the
retina.
- Secondary endpoints – These included assessment of
whether EYLEA reduced the risk of worsening disease – specifically
progression to PDR (including anterior segment neovascularization
[ASNV]) or the development of center-involved DME – as well as
change in visual acuity.
Key one-year results included:
|
EYLEA
Every 16-Week
Regimen
(N=135)
|
EYLEA
Every 8-Week
Regimen
(N=134)
|
Sham
Control
(N=133)
|
Primary
Endpoint
|
Patients with ≥2‑step
improvement on DRSS score from baseline
|
65%
|
80%
|
15%
|
Composite Endpoint
of Developing PDR or ASNVa
|
Event
Rateb
|
4%d
|
2%d
|
20%d
|
Hazard
Ratio
|
0.15
|
0.12
|
|
Development of
PDRc
|
Event
Rateb
|
2%d
|
0%d
|
12%d
|
Hazard
Ratio
|
0.11
|
0.00
|
|
a As diagnosed by either the Reading Center or Investigator through week
52
b Estimated using Kaplan-Meier method
c Defined as ≥2-step worsening on the ETDRS-DRSS score
through week 52
d p<0.01 compared with Control
Safety data observed in 269 patients with NPDR through the first
year were consistent with those seen in the Phase 3 VIVID and VISTA
trials.
About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a VEGF inhibitor
formulated as an injection for the eye. It is designed to block the
growth of new blood vessels and decrease the ability of fluid to
pass through blood vessels (vascular permeability) in the eye by
blocking VEGF-A and placental growth factor (PLGF), two growth
factors involved in angiogenesis. In the U.S., EYLEA is the
market-leading, FDA-approved anti-VEGF treatment for its approved
indications and is supported by a robust body of research that
includes eight pivotal Phase 3 trials.
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
- EYLEA® (aflibercept) Injection is
contraindicated in patients with ocular or periocular infections,
active intraocular inflammation, or known hypersensitivity to
aflibercept or to any of the excipients in EYLEA.
- Intravitreal injections, including those with EYLEA, have been
associated with endophthalmitis and retinal detachments. Proper
aseptic injection technique must always be used when administering
EYLEA. Patients should be instructed to report any symptoms
suggestive of endophthalmitis or retinal detachment without delay
and should be managed appropriately. Intraocular inflammation has
been reported with the use of EYLEA.
- Acute increases in intraocular pressure have been seen within
60 minutes of intravitreal injection, including with EYLEA.
Sustained increases in intraocular pressure have also been reported
after repeated intravitreal dosing with VEGF inhibitors.
Intraocular pressure and the perfusion of the optic nerve head
should be monitored and managed appropriately.
- There is a potential risk of arterial thromboembolic events
(ATEs) following intravitreal use of VEGF inhibitors, including
EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial
infarction, or vascular death (including deaths of unknown cause).
The incidence of reported thromboembolic events in wet AMD studies
during the first year was 1.8% (32 out of 1824) in the combined
group of patients treated with EYLEA compared with 1.5% (9 out of
595) in patients treated with ranibizumab; through 96 weeks, the
incidence was 3.3% (60 out of 1824) in the EYLEA group compared
with 3.2% (19 out of 595) in the ranibizumab group. The incidence
in the DME studies from baseline to week 52 was 3.3% (19 out of
578) in the combined group of patients treated with EYLEA compared
with 2.8% (8 out of 287) in the control group; from baseline to
week 100, the incidence was 6.4% (37 out of 578) in the combined
group of patients treated with EYLEA compared with 4.2% (12 out of
287) in the control group. There were no reported thromboembolic
events in the patients treated with EYLEA in the first six months
of the RVO studies.
- Serious adverse reactions related to the injection procedure
have occurred in <0.1% of intravitreal injections with EYLEA
including endophthalmitis and retinal detachment.
- The most common adverse reactions (≥5%) reported in patients
receiving EYLEA were conjunctival hemorrhage, eye pain, cataract,
vitreous detachment, vitreous floaters, and intraocular pressure
increased.
INDICATIONS
EYLEA®
(aflibercept) Injection 2 mg (0.05 mL) is indicated for the
treatment of patients with Neovascular (Wet) Age-related Macular
Degeneration (AMD), Macular Edema following Retinal Vein Occlusion
(RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy
(DR).
DOSAGE AND ADMINISTRATION
Diabetic Macular Edema (DME) and Diabetic Retinopathy
(DR)
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered
by intravitreal injection every 4 weeks (approximately every 28
days, monthly) for the first 5 injections followed by 2 mg (0.05
mL) via intravitreal injection once every 8 weeks (2
months).
- Although EYLEA may be dosed as frequently as 2 mg every
4 weeks (approximately every 25 days, monthly), additional
efficacy was not demonstrated in most patients when EYLEA was dosed
every 4 weeks compared to every 8 weeks. Some patients
may need every 4 week (monthly) dosing after the first
20 weeks (5 months).
Neovascular (Wet) Age-Related Macular Degeneration
(AMD)
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered
by intravitreal injection every 4 weeks (approximately every 28
days, monthly) for the first 3 months, followed by 2 mg (0.05 mL)
via intravitreal injection once every 8 weeks
(2 months).
- Although EYLEA may be dosed as frequently as 2 mg every
4 weeks (approximately every 25 days, monthly), additional
efficacy was not demonstrated in most patients when EYLEA was dosed
every 4 weeks compared to every 8 weeks. Some patients may need
every 4 week (monthly) dosing after the first 12 weeks (3
months).
- Although not as effective as the recommended every 8 week
dosing regimen, patients may also be treated with one dose every 12
weeks after one year of effective therapy. Patients should be
assessed regularly.
Macular Edema Following Retinal Vein Occlusion (RVO)
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered
by intravitreal injection once every 4 weeks (approximately every
25 days, monthly).
For more information, please see full Prescribing Information.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved medicines and
numerous product candidates in development, all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye disease, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, neuromuscular diseases, infectious diseases and rare
diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
such as VelocImmune® which produces
optimized fully-human antibodies, and ambitious research
initiatives such as the Regeneron Genetics Center, which is
conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please
visit www.regeneron.com or follow @Regeneron on
Twitter.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such
as "anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying
words. These statements concern, and these risks and
uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
EYLEA® (aflibercept) Injection; unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed
products; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in other studies and lead to therapeutic
applications; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products (such as EYLEA), research
and clinical programs, and business, including those relating to
patient privacy; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
products and product candidates; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
products and product candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; the ability of Regeneron's collaborators,
suppliers, or other third parties to perform (as applicable)
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; the availability and extent of reimbursement of
the Company's products (such as EYLEA) from third-party payers,
including private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
guidance; the potential for any license or collaboration agreement,
including Regeneron's agreements with Sanofi, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto, including without limitation the patent litigation and
other related proceedings relating to EYLEA, Dupixent®
(dupilumab) Injection, and Praluent®(alirocumab)
Injection, the ultimate outcome of any such proceedings, and the
impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2018 and its Form 10-Q for the
quarterly period ended March 31,
2019. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to
update publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Regeneron Contacts:
Media Relations
Daren
Kwok
Tel: +1 (914) 847-1328
daren.kwok@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
Mark.Hudson@regeneron.com
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