TARRYTOWN, N.Y., Aug. 13, 2019 /PRNewswire/ --
EYLEA is the only anti-VEGF approved to treat four retinal
conditions with a single dose strength prefilled syringe
EYLEA is available in multiple dosing intervals, offering
doctors flexibility to address patients' individual needs
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that the U.S. Food and Drug Administration (FDA) has
approved the Chemistry, Manufacturing and Controls (CMC)
Prior-Approval Supplement (PAS) for the
EYLEA® (aflibercept) Injection prefilled syringe.
The 2 mg, single-dose, sterilized prefilled syringe provides
physicians with a new way to administer EYLEA that requires fewer
preparation steps compared to vials. Market supply of the EYLEA
prefilled syringe is expected to be available to physicians and
patients this year.
"With eight pivotal Phase 3 trials and millions of injections
used around the world, EYLEA sets a high bar for visual acuity and
safety across multiple retinal diseases, including wet age-related
macular degeneration and diabetic eye diseases," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "This approval may help
doctors more conveniently and efficiently deliver EYLEA to
appropriate patients."
The sterilized prefilled syringe offers the same medicine as the
currently available EYLEA, in an easier to use and administer
presentation.
In the U.S., EYLEA is indicated to treat neovascular (wet)
age-related macular degeneration (Wet AMD), macular edema following
retinal vein occlusion (RVO), diabetic macular edema (DME) and
diabetic retinopathy (DR).
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 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).
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 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, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, infectious diseases, pain 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; 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;
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;
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; 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 (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; 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 June 30,
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
Joseph
Ricculli
Tel: +1 (914) 418-0405
Joseph.Ricculli@regeneron.com
Investor Relations
Justin
Holko
Tel: +1 (914) 847-7786
Justin.Holko@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.