TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the U.S. Food and Drug Administration (FDA) has approved a
supplemental Biologics License Application (sBLA) for
EYLEA® (aflibercept) Injection in patients with wet
age-related macular degeneration (wet AMD). The sBLA was based on
second-year data from the Phase 3 VIEW 1 and 2 trials in which
patients with wet AMD were treated with a modified 12-week dosing
schedule (doses given at least every 12 weeks, and additional doses
as needed). These data are now included in the updated EYLEA
label.
"We are pleased that the FDA has approved an updated label for
EYLEA," said George D. Yancopoulos,
M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
"Providing information to retinal physicians about the visual
outcomes with a modified 12-week dosing schedule will help
physicans make the most informed choices in treating patients
suffering from wet age-related macular degeneration."
EYLEA is also approved in wet AMD for every four- or eight-week
dosing intervals after three initial monthly doses.
About EYLEA®
(aflibercept)
Injection
EYLEA® (aflibercept) Injection is a
vascular endothelial growth factor (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 seven
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 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) in patients with
DME.
Please visit www.EYLEA.us to see the full Prescribing
Information for EYLEA.
About Regeneron
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 six
FDA-approved treatments 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, heart disease, allergic and inflammatory diseases, pain,
cancer, 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, including without limitation
EYLEA; 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 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
proceedings relating to EYLEA,
Dupixent® (dupilumab) Injection, and
Praluent®(alirocumab) Injection, the ultimate outcome of
any such litigation 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-Q for the quarterly period ended June 30, 2018. 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).
Contacts Regeneron:
Media Relations
Daren
Kwok
Tel: +1 (914) 847-1328
daren.kwok@regeneron.com
Investor Relations
Manisha Narasimhan, Ph.D.
Tel: +1 (914) 847-5126
manisha.narasimhan@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.