Apellis Plans to Seek Re-Examination Following Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU
28 Junio 2024 - 5:57AM
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a negative opinion on
the marketing authorization application (MAA) of intravitreal
pegcetacoplan for the treatment of geographic atrophy (GA).
Notably, there were multiple dissenting votes by CHMP members to
this opinion. Apellis plans to seek re-examination and expects a
final opinion in the fourth quarter of 2024. Today’s opinion
followed an Ad Hoc Expert Group meeting, in which the experts
agreed that size of GA lesion is an acceptable primary outcome
measure for a trial in GA and that microperimetry is the best
available functional measure in GA.
As previously announced, this review was led by the original
rapporteurs following the EMA reset to Day 180 of the initial MAA
assessment procedure.
“We remain steadfast in our commitment to GA patients in Europe
who have no treatment for this devastating disease, which leads to
irreversible vision loss,” said Jeffrey Eisele, Ph.D., chief
development officer, Apellis. “It is encouraging to see the broad
support for pegcetacoplan within the European retina community, and
we are focused on promptly initiating the re-examination to bring
this important treatment to those in need.”
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.1,2 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.3
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 StatementStatements 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. 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 pegcetacoplan 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 27, 2024 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: Tracy
Vineismedia@apellis.com617.420.4839
Investor Contact:Meredith
Kayameredith.kaya@apellis.com617.599.8178
1Rudnicka 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;119:571–580.2Wong 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:e106–116.3Lindblad AS, et al, and AREDS Research
Group. Arch Ophthalmol. 2009;127(9):1168-1174.
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