Apellis Announces Negative CHMP Opinion for Pegcetacoplan for GA in the European Union and Plans to Seek Re-Examination of Application
26 Janvier 2024 - 1:06PM
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency has adopted a negative opinion on the
marketing authorization application (MAA) of intravitreal
pegcetacoplan for the treatment of geographic atrophy (GA)
secondary to age-related macular degeneration (AMD). As previously
announced, this opinion was expected based on a negative trend vote
following an oral explanation meeting in December 2023. Apellis
plans to seek immediate re-examination of its application.
“We are very disappointed in this outcome on behalf of the
millions of Europeans with GA who currently have no treatment
options for this irreversible form of blindness,” said Jeffrey
Eisele, Ph.D., chief development officer, Apellis. “We plan to
promptly initiate the re-examination of our application and address
CHMP questions, with the goal of bringing this first-ever potential
treatment to the GA community in Europe.”
The MAA is based on results from the Phase 3 OAKS and DERBY
studies at 24 months, which were published in The Lancet.
Treatment with both every-other-month and monthly pegcetacoplan
reduced GA lesion growth with increasing treatment effects over
time and showed a well-demonstrated safety profile. Additionally,
pegcetacoplan preserved visual function longer in multiple post hoc
Phase 3 analyses that have been presented at medical
congresses.
More than 2.5 million people in Europe are living with GA,1 a
progressive and irreversible form of vision loss that severely
impairs independence and quality of life.
About the Phase 3 OAKS and DERBY StudiesOAKS
(n=637) and DERBY (n=621) are Phase 3, multicenter, randomized,
double-masked, sham-controlled studies comparing the efficacy and
safety of intravitreal pegcetacoplan with sham injections across a
broad and heterogenous population of patients with geographic
atrophy (GA) secondary to age-related macular degeneration (AMD).
The studies evaluated the efficacy of monthly and every-other-month
pegcetacoplan in patients with GA assessed by change in the total
area of GA lesions from baseline as measured by fundus
autofluorescence.
About Geographic Atrophy (GA)Geographic atrophy
(GA) is an advanced form of age-related macular degeneration and a
leading cause of blindness worldwide, impacting more than one
million Americans and five million people worldwide.2,3 It is a
progressive and irreversible disease caused by the growth of
lesions, which destroy the retinal cells responsible for vision.
The vision loss caused by GA severely impairs independence and
quality of life by making it difficult to participate in daily
activities. On average, it takes only 2.5 years for GA lesions to
start impacting the fovea, which is responsible for central
vision.4
About Pegcetacoplan for Geographic Atrophy
(GA)Pegcetacoplan is an investigational, targeted C3
therapy designed to regulate excessive activation of the complement
cascade, part of the body’s immune system, which can lead to the
onset and progression of many serious diseases.
SYFOVRE® (pegcetacoplan injection) is approved in the United
States for the treatment of GA secondary to age-related macular
degeneration.
About Apellis Apellis Pharmaceuticals,
Inc. is a global biopharmaceutical company that combines courageous
science and compassion to develop life-changing therapies for some
of the most challenging diseases patients face. We ushered in the
first new class of complement medicine in 15 years and now have two
approved medicines targeting C3. These include the first-ever
therapy for geographic atrophy, a leading cause of blindness around
the world. We believe we have only begun to unlock the potential of
targeting C3 across serious retinal, rare, and neurological
diseases. For more information, please visit
http://apellis.com or follow us
on Twitter and LinkedIn.
Apellis Forward-Looking
Statement Statements in this press release about
future expectations, plans and prospects, as well as any other
statements regarding matters that are not historical facts, may
constitute “forward-looking statements” within the meaning of The
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements regarding the Company’s
plan to seek re-examination of the MAA . The words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including whether the benefit/risk profile of SYFOVRE
following the reported events of retinal vasculitis will impact our
commercialization efforts; whether SYFOVRE will receive approval
from foreign regulatory agencies for GA when expected or at all,
including the impact on the likelihood and timing of such
approvals; and other factors discussed in the “Risk Factors”
section of Apellis’ Annual Report on Form 10-K with the Securities
and Exchange Commission on February 21, 2023 and Quarterly Report
on Form 10-Q filed on November 1, 2023 and the risks described in
other filings that Apellis may make with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Apellis
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise.Media Contact: Lissa
Pavluk media@apellis.com617.977.6764
Investor Contact: Meredith
Kaya meredith.kaya@apellis.com617.599.8178
1Apellis data on file reflecting analysis of Colijin et al.,
2016; Wong et al. 2014; Rudnicka et al., 2014; Korb et al., 2014;
Piermarocchi et al., 2011; Fernandez-Arias et al., 2011; Augood et
al., 2006.2Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender
variations in age-related macular degeneration prevalence in
populations of European ancestry: a meta
analysis. Ophthalmology 2012;119:571–580.3Wong WL, Su X,
Li X, et al. Global prevalence of age-related macular degeneration
and disease burden projection for 2020 and 2040: a systematic
review and meta-analysis. Lancet Glob
Health 2014;2:e106–116.4 Lindblad AS, et al, and AREDS
Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
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