Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global
biopharmaceutical company and leader in complement, today announced
that seven abstracts will be presented at the hybrid European
Hematology Association (EHA) Congress to be held June 9-12 in
Vienna, Austria. Data to be presented reinforce the robust efficacy
and safety profile of EMPAVELI® (pegcetacoplan) for the
treatment of paroxysmal nocturnal hemoglobinuria (PNH).
“Our presence at EHA this year continues to underscore the
potential of EMPAVELI to become the new standard of care for all
adults living with PNH,” said Federico Grossi, M.D., Ph.D., chief
medical officer of Apellis.
Oral Presentation:
- Effect of Pegcetacoplan on Quality of Life in
Complement-Inhibitor Naïve Patients with Paroxysmal Nocturnal
Hemoglobinuria: Results from the Phase 3 PRINCE Study – #S303 –
Saturday, June 11 – 11:30-12:45 CEST
Poster Presentations:
- Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with
Pegcetacoplan Show Improvements in D-dimer Normalization and
Decrease in Incidence of Thrombosis – #P839 -Friday, June 10 –
16:30-17:45 CEST
- A Matching-Adjusted Indirect Comparison of the Efficacy of
Pegcetacoplan Using PRINCE Trial Data Versus Ravulizumab and
Eculizumab in Complement-Naïve Patients with Paroxysmal Nocturnal
Hemoglobinuria – #P840 – Friday, June 10 – 16:30-17:45 CEST
- Normalization of Hematologic and Health-Related Quality of Life
Markers in Patients with Paroxysmal Nocturnal Hemoglobinuria
Treated with Pegcetacoplan and Baseline Hemoglobin at or above 10
g/dL – #P828 – Friday, June 10 – 16:30-17:45 CEST
- Pegcetacoplan Rapidly Stabilizes Complement Inhibitor Naïve
Patients with Paroxysmal Nocturnal Hemoglobinuria Experiencing
Hemolysis with Acute Hemoglobin Decreases; PRINCE Trial Post Hoc
Analysis – #P838 – Friday, June 10 – 16:30-17:45 CEST
- Categorizing Hematological Response to Pegcetacoplan in
Patients with Paroxysmal Nocturnal Hemoglobinuria: A Post Hoc
Analysis of the Phase 3 PRINCE Study Data – #P833 – Friday, June 10
– 16:30-17:45 CEST
- A Real-World Analysis of Healthcare Resource Utilization Among
Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received
Treatment with Ravulizumab – #P1747 – Friday, June 10 – 16:30-17:45
CEST
About
EMPAVELI®/Aspaveli® (pegcetacoplan)EMPAVELI®/Aspaveli® (pegcetacoplan)
is a 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.
EMPAVELI is approved for the treatment of paroxysmal nocturnal
hemoglobinuria (PNH) in the United States, Australia, and Saudi
Arabia, and Aspaveli, which is the European trade name for
pegcetacoplan, is approved in the European Union and the United
Kingdom. The therapy is also under investigation for several other
rare diseases across hematology, nephrology, and neurology.
U.S. Important Safety Information for
EMPAVELI
BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED
BACTERIA
- Meningococcal infections may
occur in patients treated with EMPAVELI and may become rapidly
life-threatening or fatal if not recognized and treated early. Use
of EMPAVELI may predispose individuals to serious infections,
especially those caused by encapsulated bacteria, such
as Streptococcus
pneumoniae, Neisseria
meningitidis types A, C, W, Y, and B,
and Haemophilus
influenzae type B.
- Comply with the most current
Advisory Committee on Immunization Practices (ACIP) recommendations
for vaccinations against encapsulated bacteria.
- Vaccinate patients at least
2 weeks prior to administering the first dose of EMPAVELI
unless the risks of delaying therapy with EMPAVELI outweigh the
risk of developing a serious infection.
- Vaccination reduces, but does
not eliminate, the risk of serious infections. Monitor patients for
early signs of serious infections and evaluate immediately if
infection is suspected.
- EMPAVELI is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS). Under the
EMPAVELI REMS, prescribers must enroll in the
program.
CONTRAINDICATIONS
- Hypersensitivity to pegcetacoplan or to
any of the excipients
- Not currently vaccinated against
certain encapsulated bacteria, unless the risks of delaying
EMPAVELI treatment outweigh the risks of developing a bacterial
infection with an encapsulated organism
- Unresolved serious infection caused by encapsulated bacteria
including Streptococcus pneumoniae, Neisseria
meningitidis, and Haemophilus influenzae
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated
BacteriaThe use of EMPAVELI may predispose individuals to
serious, life-threatening, or fatal infections caused by
encapsulated bacteria, including Streptococcus
pneumoniae, Neisseria meningitidis types A, C, W, Y, and
B, and Haemophilus influenzae type B (Hib). To reduce the
risk of infection, all patients must be vaccinated against these
bacteria according to the most current ACIP recommendations for
patients with altered immunocompetence associated with complement
deficiencies. Revaccinate patients in accordance with ACIP
recommendations considering the duration of therapy with
EMPAVELI.
For patients without known history of vaccination, administer
required vaccines at least 2 weeks prior to receiving the first
dose of EMPAVELI. If immediate therapy with EMPAVELI is indicated,
administer required vaccine as soon as possible and provide
patients with 2 weeks of antibacterial drug prophylaxis.
Closely monitor patients for early signs and symptoms of serious
infection and evaluate patients immediately if an infection is
suspected. Promptly treat known infections. Serious infection may
become rapidly life-threatening or fatal if not recognized and
treated early. Consider discontinuation of EMPAVELI in patients who
are undergoing treatment for serious infections.
EMPAVELI REMSBecause of the risk of serious
infections, EMPAVELI is available only through a restricted program
under a REMS. Under the EMPAVELI REMS, prescribers must enroll in
the program and must counsel patients about the risk of serious
infection, provide the patients with the REMS educational
materials, and ensure patients are vaccinated against encapsulated
bacteria. Enrollment and additional information are available by
telephone: 1-888-343-7073 or at www.empavelirems.com.
Infusion-Related ReactionsSystemic
hypersensitivity reactions (e.g., facial swelling, rash, urticaria)
have occurred in patients treated with EMPAVELI. One patient (less
than 1% in clinical studies) experienced a serious allergic
reaction which resolved after treatment with antihistamines. If a
severe hypersensitivity reaction (including anaphylaxis) occurs,
discontinue EMPAVELI infusion immediately, institute appropriate
treatment, per standard of care, and monitor until signs and
symptoms are resolved.
Monitoring PNH Manifestations after Discontinuation of
EMPAVELIAfter discontinuing treatment with EMPAVELI,
closely monitor for signs and symptoms of hemolysis, identified by
elevated LDH levels along with sudden decrease in PNH clone size or
hemoglobin, or reappearance of symptoms such as fatigue,
hemoglobinuria, abdominal pain, dyspnea, major adverse vascular
events (including thrombosis), dysphagia, or erectile dysfunction.
Monitor any patient who discontinues EMPAVELI for at least 8 weeks
to detect hemolysis and other reactions. If hemolysis, including
elevated LDH, occurs after discontinuation of EMPAVELI, consider
restarting treatment with EMPAVELI.
Interference with Laboratory TestsThere may be
interference between silica reagents in coagulation panels and
EMPAVELI that results in artificially prolonged activated partial
thromboplastin time (aPTT); therefore, avoid the use of silica
reagents in coagulation panels.
ADVERSE REACTIONSThe most common adverse
reactions (incidence ≥10% of patients) with EMPAVELI vs. eculizumab
were injection-site reactions (39% v. 5%), infections (29% v. 26%),
diarrhea (22% v. 3%), abdominal pain (20% v. 10%), respiratory
tract infection (15% v. 13%), viral infection (12% v. 8%), and
fatigue (12% v. 23%).
USE IN SPECIFIC POPULATIONSFemales of
Reproductive PotentialEMPAVELI may cause embryo-fetal harm when
administered to pregnant women. Pregnancy testing is recommended
for females of reproductive potential prior to treatment with
EMPAVELI. Advise female patients of reproductive potential to use
effective contraception during treatment with EMPAVELI and for 40
days after the last dose.
Please see full Prescribing
Information, including Boxed
WARNING regarding serious infections caused by
encapsulated bacteria, and Medication
Guide.
About Paroxysmal Nocturnal Hemoglobinuria
(PNH)PNH is a rare, chronic, life-threatening blood
disorder characterized by the destruction of oxygen-carrying red
blood cells through extravascular and intravascular hemolysis.
Persistently low hemoglobin can result in frequent transfusions and
debilitating symptoms such as severe fatigue, hemoglobinuria and
difficulty breathing (dyspnea).
About the Apellis and Sobi CollaborationApellis
and Sobi have global co-development rights for systemic
pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights
for systemic pegcetacoplan, and Apellis has exclusive U.S.
commercialization rights for systemic pegcetacoplan and worldwide
commercial rights for ophthalmological pegcetacoplan, including for
geographic atrophy.
About Apellis Apellis
Pharmaceuticals, Inc. is a global biopharmaceutical company that is
committed to leveraging courageous science, creativity, and
compassion to deliver life-changing therapies. Leaders in
complement, we ushered in the first new class of complement
medicine in 15 years with the approval of the first and only
targeted C3 therapy. We are advancing this science to continually
develop transformative medicines for people living with rare,
retinal, 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 discussed in the “Risk Factors” section
of Apellis’ Quarterly Report on Form 10-Q with the Securities and
Exchange Commission on May 4, 2022 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
Pavlukmedia@apellis.com617.977.6764
Investor Contact: Meredith
Kaya meredith.kaya@apellis.com617.599.8178
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