FDA Issues Complete Response Letter (CRL) for Aflibercept 8 mg Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-party Filler
June 27 2023 - 1:45PM
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the U.S. Food and Drug Administration (FDA) has issued a Complete
Response Letter (CRL) for the Biologics License Application (BLA)
for aflibercept 8 mg for the treatment of patients with wet
age-related macular degeneration (wAMD), diabetic macular edema
(DME) and diabetic retinopathy (DR), solely due to an ongoing
review of inspection findings at a third-party filler. The CRL did
not identify any issues with the aflibercept 8 mg clinical efficacy
or safety, trial design, labeling or drug substance manufacturing,
and no additional clinical data or trials have been requested.
Regeneron is committed to working closely with the FDA and the
third-party filler to bring aflibercept 8 mg to patients with wAMD,
DME and DR as quickly as possible.
Aflibercept 8 mg is being jointly developed
by Regeneron and Bayer AG. In the U.S., Regeneron
maintains exclusive rights to EYLEA® (aflibercept) Injection and
aflibercept 8 mg. Bayer has licensed the exclusive marketing rights
outside of the U.S., where the companies share equally the
profits from sales of EYLEA and future sales of aflibercept 8 mg
following any regulatory approvals.
Aflibercept 8 mg is investigational, and its safety and efficacy
have not been approved by any regulatory authority. Regulatory
filings for aflibercept 8 mg are under review in Europe and Japan.
Submissions to other regulatory authorities in additional countries
are also planned.
About RegeneronRegeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to 9 FDA-approved treatments and numerous
product candidates in development, almost 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, pain, hematologic conditions, infectious diseases and
rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite®
technologies, such as VelocImmune®, which uses unique genetically
humanized mice to produce optimized fully human antibodies and
bispecific antibodies, and through ambitious research initiatives
such as the Regeneron Genetics Center®, which is conducting one of
the largest genetics sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow
@Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
MediaThis 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 products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Products”) and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Product Candidates”) and research and clinical
programs now underway or planned, including without limitation
aflibercept 8 mg; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron’s Product
Candidates (such as aflibercept 8 mg, including based on the
Biologics License Application discussed in this press release (the
“aflibercept 8 mg BLA”)) and new indications for Regeneron’s
Products; the impact of the Complete Response Letter for the
aflibercept 8 mg BLA discussed in this press release (the “CRL”) on
the timing of the potential approval of aflibercept 8 mg by the
U.S. Food and Drug Administration (the “FDA”) and whether and how
timely Regeneron is able to resolve the issues identified in the
CRL; uncertainty of the utilization, market acceptance, and
commercial success of Regeneron’s Products and Regeneron’s Product
Candidates (such as aflibercept 8 mg) and the impact of studies
(whether conducted by Regeneron or others and whether mandated or
voluntary), including the studies discussed or referenced in this
press release, on any of the foregoing or any potential regulatory
approval of Regeneron’s Products and Regeneron’s Product
Candidates; the ability of Regeneron’s collaborators, licensees,
suppliers, or other third parties (as applicable) (including the
third-party filler referenced in this press release) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps (as applicable) related to
Regeneron’s Products and Regeneron’s Product Candidates; the
ability of Regeneron to manage supply chains for multiple products
and product candidates; safety issues resulting from the
administration of Regeneron’s Products (such as aflibercept 8 mg)
and Regeneron’s Product Candidates in patients, including serious
complications or side effects in connection with the use of
Regeneron’s Products and Regeneron’s Product Candidates in clinical
trials; 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 Regeneron’s Product Candidates; ongoing regulatory
obligations and oversight impacting Regeneron’s Products, research
and clinical programs, and business, including those relating to
patient privacy; the availability and extent of reimbursement of
Regeneron’s Products (including aflibercept 8 mg) 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, or more cost effective
than, Regeneron’s Products and Regeneron’s Product Candidates; the
extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators or
licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; 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, collaboration, or supply
agreement, including Regeneron’s agreements with Sanofi and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; 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® (aflibercept)
Injection, Praluent® (alirocumab), and
REGEN-COV® (casirivimab and imdevimab)), other litigation and
other proceedings and government investigations relating to the
Company and/or its operations, the ultimate outcome of any such
proceedings and investigations, 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, 2022 and its Form
10-Q for the quarterly period ended March 31, 2023. 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 or otherwise) 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
RelationsMary HeatherTel: +1
914-847-8650mary.heather@regeneron.com |
Investor
RelationsMark HudsonTel: +1
914-847-3482mark.hudson@regeneron.com |
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