TARRYTOWN, N.Y., Sept. 13,
2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the supplemental Biologics License
Application (sBLA) of EYLEA® (aflibercept) Injection for
the treatment of diabetic retinopathy (DR), the leading cause of
vision loss for patients with diabetes. The target action date for
the FDA decision is May 13, 2019.
The sBLA submission is based on results from the Phase 3
PANORAMA trial investigating EYLEA as a treatment for patients with
moderately severe to severe non-proliferative diabetic retinopathy
(NPDR) without diabetic macular edema (DME). Positive six-month
topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are
expected to be shared later this year.
The safety and efficacy of the potential use of EYLEA in DR
without DME has not been fully evaluated by any regulatory
authority.
EYLEA is administered as a 2 mg intravitreal injection and
currently indicated to treat wet age-related macular degeneration,
macular edema following retinal vein occlusion, DME, and DR in
patients with DME.
About Diabetic Retinopathy
Approximately eight million
people live with DR, a disease characterized by microvascular
damage to the blood vessels in the retina often caused by poor
blood sugar control in people with diabetes. The disease generally
starts as NPDR and often has no warning signs or symptoms. NPDR may
progress to proliferative diabetic retinopathy (PDR), a stage of
the disease in which abnormal blood vessels grow onto the surface
of the retina and potentially cause severe, vision-threatening
complications such as vitreous hemorrhage and traction retinal
detachment.
DME can occur at any stage of DR as the blood vessels in the
retina become increasingly fragile and leak fluid, potentially
causing visual impairment. In the U.S., approximately 1.5 million
adults are diagnosed with DME, while approximately 3.5 million
people suffer from DR without DME.
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 by
physician-scientists for 30 years, our unique ability to repeatedly
and consistently translate science into medicine has led to six
FDA-approved treatments and over a dozen product candidates, all of
which were homegrown in our laboratories. Our medicines and
pipeline are designed to help patients with eye diseases, 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 its proprietary
VelociSuite® technologies, including
VelocImmune® to yield optimized fully-human
antibodies, and ambitious initiatives such as the Regeneron
Genetics Center, 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.
Regeneron 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, such as the potential
approval of EYLEA for the treatment of diabetic retinopathy without
diabetic macular edema by the U.S. Food and Drug Administration
based on the supplemental Biologics License Application discussed
in this news release; 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
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:
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.