New insights from industry-leading portfolio
will demonstrate the impact of C5 inhibition in treating patients
with gMG and NMOSD
Data will showcase breadth and potential of
early to late stage rare disease pipeline
Alexion, AstraZeneca Rare Disease, will showcase the potential
for its pioneering therapies to redefine the treatment landscape
for certain rare neurological diseases at the American Academy of
Neurology (AAN) Annual Meeting, April 22-27, 2023. The company will
present 19 abstracts, including eight oral presentations, across
generalized myasthenia gravis (gMG), neuromyelitis optica spectrum
disorder (NMOSD), Wilson disease and dermatomyositis.
Presentations of clinical and real-world evidence will offer new
insights about the efficacy and safety of ULTOMIRIS®
(ravulizumab-cwvz) and SOLIRIS® (eculizumab) and the crucial role
C5 inhibition can play in improving outcomes for patients with the
most common forms of gMG and NMOSD. New Phase I data for
gefurulimab (ALXN1720), an investigational, self-administered,
third generation C5 complement inhibitor, will further support
ongoing Phase III clinical development in gMG, representing
continued innovation for the rare disease community.
Marc Dunoyer, Chief Executive Officer, Alexion, said: “Our
presentations at AAN reinforce the depth and strength of our
expanding rare neurology portfolio and demonstrate the potential
for our C5 inhibitors to transform care for people living with gMG
and NMOSD. We continue to deliver on our commitment to understand
patient experiences and innovate to meet the needs of the rare
disease communities we serve.”
Delivering on the promise of C5 inhibition in rare
neurology
Presentations will expand on results from the CHAMPION-MG Phase
III trial, which supported the US approval of ULTOMIRIS, the first
and only long-acting C5 complement inhibitor, for adults with
anti-acetylcholine receptor (AChR) antibody-positive (Ab+) gMG.
This includes an exploratory analysis showing patients who received
ULTOMIRIS were more likely to see improvements in overall disease
status as compared to placebo.
Additionally, findings from a US-based disease registry will
provide real-world evidence for first-in-class C5 inhibitor
SOLIRIS, demonstrating treatment response for the majority of gMG
patients in a broad representative population. Further, poster
presentations will be showcased for gefurulimab (ALXN1720), an
investigational C5 inhibitor optimized for subcutaneous
administration, including trial design and methodology for the
ongoing PREVAIL Phase III trial in adults with AChR Ab+ gMG.
New data on pharmacodynamics and pharmacokinetics and updated
analyses from the CHAMPION-NMOSD Phase III trial will reinforce the
critical benefits of C5 inhibition in anti-aquaporin-4 (AQP4) Ab+
NMOSD treatment and the potential of ULTOMIRIS to substantially
reduce the risk of relapse in a broad range of patients.
Improving awareness of patient experiences
A poster presentation will share insights from interviews with
NMOSD patients to help illustrate the debilitating effects of NMOSD
on mobility and activities of daily living. These findings will
contribute to a more robust and authentic understanding of the
lasting impact of this disease, underscoring the importance of
timely treatment in NMOSD to prevent relapses that can result in
cumulative disability.
Alexion presentations during AAN 2023
Lead author
Abstract title
Presentation details
gMG
Bril, Vera
Ravulizumab in adults with generalized
myasthenia gravis: A sub-analysis of the Phase 3 CHAMPION MG study,
according to chronic IVIg use at study entry
Poster Presentation P1.5-013 April 23,
2023 8:00 – 9:00 AM ET
Muppidi, Srikanth
Achievement of improved post-intervention
status in patients with generalized myasthenia gravis treated with
ravulizumab during the CHAMPION MG study
Oral Presentation S5.008 April 23, 2023
2:24 PM ET
Habib, Ali
Ravulizumab for the treatment of
generalized myasthenia gravis: timing of response
Poster Presentation P1.5-004 April 23,
2023 8:00 – 9:00 AM ET
Basoff, Daniel
Comorbidities in patients with myasthenia
gravis in the USA: a retrospective claims database analysis
Poster Presentation P1.5-003 April 23,
2023 8:00 – 9:00 AM ET
Rodrigues, Ema
Incidence and prevalence of myasthenia
gravis in the United States: a claims-based analysis
Oral Presentation S19.007 April 24, 2023
4:42 PM ET
Greene, Ericka
Myasthenia gravis activities of daily
living (MG-ADL) response to eculizumab treatment in patients from
the Generalized Myasthenia Gravis Registry
Poster Presentation P1.5-020 April 23,
2023 8:00 – 9:00 AM ET
Pulley, Michael
Change in concomitant therapies for
generalized myasthenia gravis in patients receiving eculizumab: a
retrospective analysis of registry data
Poster Presentation P1.5-002 April 23,
2023 8:00 – 9:00 AM ET
Brandsema, John
A Phase 3, open-label, multicenter study
to evaluate eculizumab in adolescents with refractory generalized
myasthenia gravis
Oral Presentation S5.009 April 23, 2023
2:36 PM ET
Ortiz, Stephan
Safety, tolerability, pharmacokinetics,
pharmacodynamics and immunogenicity of subcutaneous and intravenous
ALXN1720 in healthy volunteers: a Phase 1, randomized,
double-blind, placebo-controlled, single and multiple ascending
dose study
Poster Presentation P1.5-016 April 23,
2023 8:00 – 9:00 AM ET
Howard, James
Study design and methodology of the
PREVAIL trial: a Phase 3, randomized, double-blind,
placebo-controlled study of the safety and efficacy of subcutaneous
ALXN1720 in adults with generalized myasthenia gravis
Poster Presentation P1.5-008 April 23,
2023 8:00 – 9:00 AM ET
Laforêt, Pascal
Identifying digital biomarkers for the
self-monitoring of patients living with generalized myasthenia
gravis: a proof of concept*
Poster Presentation P7.8-007 April 25,
2023 8:00 – 9:00 AM ET
NMOSD
Ortiz, Stephan
Pharmacokinetics and pharmacodynamics of
ravulizumab in adults with anti-aquaporin-4 antibody-positive
neuromyelitis optica spectrum disorder during the Phase 3
CHAMPION-NMOSD trial
Oral Presentation S5.004 April 23, 2023
1:36 PM ET
Pittock, Sean
Efficacy and safety of ravulizumab in
adults with anti-aquaporin-4 antibody-positive neuromyelitis optica
spectrum disorder: outcomes from the Phase 3 CHAMPION-NMOSD
trial
Oral Presentation S5.002 April 23, 2023
1:12 PM ET
Levy, Michael
Efficacy subgroup analyses from the Phase
3 CHAMPION-NMOSD trial in adults with anti-aquaporin-4
antibody-positive neuromyelitis optica spectrum disorder
Oral Presentation S5.003 April 23, 2023
1:24 PM ET
Bernitsas, Evanthia
Characterizing the impact of NMOSD on
mobility, daily activities, and social activities through patient
interviews
Poster Presentation P13.5-011 April 27,
2023 8:00 – 9:00 AM ET
Levy, Michael
NMOSDCopilot: feasibility of
smartphone-based digital biomarkers for the self-assessment of
vision, motor and cognitive functions in neuromyelitis optica
spectrum disorder*
Oral Presentation S50.002 April 27, 2023
3:42 PM ET
Wilson disease
Bega, Danny
Efficacy and safety of ALXN1840 versus
standard of care in Wilson disease: primary results from an ongoing
Phase 3, randomized, controlled, rater-blinded trial
Clinical Trials Plenary Session April 25,
2023 9:15 – 11:30 AM ET
Hedera, Peter
Neurological manifestations of Wilson
disease in treatment-naive patients and in patients receiving
standard of care
Poster Presentation P11.4-005 April 26,
2023 11:45 AM – 12:45 PM ET
Dermatomyositis
Kielhorn, Adrian
Treatment utilization in dermatomyositis:
an analysis of electronic medical records in the United States
Poster Presentation P9.5-032 April 25,
2023 5:30 – 6:30 PM ET
*Ad Scientiam research study supported by Alexion
INDICATION(S) & IMPORTANT SAFETY INFORMATION for
ULTOMIRIS® (ravulizumab-cwvz)
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat:
- adults and children 1 month of age and older with a disease
called Paroxysmal Nocturnal Hemoglobinuria (PNH).
- adults and children 1 month of age and older with a disease
called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not
used in treating people with Shiga toxin E. coli related hemolytic
uremic syndrome (STEC-HUS).
- adults with a disease called generalized Myasthenia Gravis
(gMG) who are anti-acetylcholine receptor (AChR) antibody
positive.
- adults with PNH or aHUS when administered subcutaneously (under
your skin).
It is not known if ULTOMIRIS is safe and effective in children
younger than 1 month of age.
It is not known if ULTOMIRIS is safe and effective for the
treatment of gMG in children.
Subcutaneous administration of ULTOMIRIS has not been evaluated
and is not approved for use in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and
can lower the ability of your immune system to fight
infections.
- ULTOMIRIS increases your chance of getting serious and
life-threatening meningococcal infections that may quickly become
life-threatening and cause death if not recognized and treated
early.
- You must receive meningococcal vaccines at least 2 weeks before
your first dose of ULTOMIRIS if you are not vaccinated.
- If your healthcare provider decided that urgent treatment with
ULTOMIRIS is needed, you should receive meningococcal vaccination
as soon as possible.
- If you have not been vaccinated and ULTOMIRIS therapy must be
initiated immediately, you should also receive 2 weeks of
antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need
additional vaccination. Your healthcare provider will decide if you
need additional vaccination.
- Meningococcal vaccines reduce but do not prevent all
meningococcal infections. Call your healthcare provider or get
emergency medical care right away if you get any of these signs and
symptoms of a meningococcal infection: headache with nausea or
vomiting, headache and fever, headache with a stiff neck or stiff
back, fever, fever and a rash, confusion, muscle aches with
flu-like symptoms and eyes sensitive to light.
Your healthcare provider will give you a Patient Safety Card
about the risk of meningococcal infection. Carry it with you at
all times during treatment and for 8 months after your last
ULTOMIRIS dose. It is important to show this card to any healthcare
provider or nurse to help them diagnose and treat you quickly.
ULTOMIRIS is only available through a program called the
ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your
healthcare provider must: enroll in the ULTOMIRIS REMS program;
counsel you about the risk of meningococcal infection; give you
information and a Patient Safety Card about the symptoms and
your risk of meningococcal infection (as discussed above); and make
sure that you are vaccinated with a meningococcal vaccine, and if
needed, get revaccinated with the meningococcal vaccine. Ask your
healthcare provider if you are not sure if you need to be
revaccinated.
ULTOMIRIS may also increase the risk of other types of
serious infections. Make sure your child receives vaccinations
against Streptococcus pneumoniae and Haemophilus influenzae type b
(Hib) if treated with ULTOMIRIS. Call your healthcare provider
right away if you have any new signs or symptoms of infection.
Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a meningococcal
infection or have not been vaccinated against meningococcal
infection unless your healthcare provider decides that urgent
treatment with ULTOMIRIS is needed.
Before you receive ULTOMIRIS, tell your healthcare provider
about all of your medical conditions, including if you: have an
infection or fever, are pregnant or plan to become pregnant, and
are breastfeeding or plan to breastfeed. It is not known if
ULTOMIRIS will harm your unborn baby or if it passes into your
breast milk. You should not breastfeed during treatment and for 8
months after your final dose of ULTOMIRIS.
Tell your healthcare provider about all the vaccines you
receive and medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements which
could affect your treatment.
If you have PNH and you stop receiving ULTOMIRIS, your
healthcare provider will need to monitor you closely for at least
16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause
breakdown of your red blood cells due to PNH. Symptoms or problems
that can happen due to red blood cell breakdown include: drop
in your red blood cell count, tiredness, blood in your urine,
stomach-area (abdomen) pain, shortness of breath, blood clots,
trouble swallowing, and erectile dysfunction (ED) in males.
If you have aHUS, your healthcare provider will need to
monitor you closely for at least 12 months after stopping treatment
for signs of worsening aHUS or problems related to a type of
abnormal clotting and breakdown of your red blood cells called
thrombotic microangiopathy (TMA). Symptoms or problems that can
happen with TMA may include: confusion or loss of
consciousness, seizures, chest pain (angina), difficulty breathing
and blood clots or stroke.
ULTOMIRIS can cause serious side effects including allergic
reactions to acrylic adhesive. Allergic reactions to the
acrylic adhesive may happen with your subcutaneous ULTOMIRIS
treatment. If you have an allergic reaction during the delivery of
subcutaneous ULTOMIRIS, remove the on-body injector and get medical
help right away. Your healthcare provider may treat you with
medicines to help prevent or treat allergic reaction symptoms as
needed.
What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including
infusion-related reactions. Symptoms of an infusion-related
reaction with ULTOMIRIS may include lower back pain, tiredness,
feeling faint, discomfort in your arms or legs, bad taste, or
drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare
provider or nurse right away if you develop these symptoms, or any
other symptoms during your ULTOMIRIS infusion that may mean you are
having a serious infusion reaction, including: chest pain, trouble
breathing or shortness of breath, swelling of your face, tongue, or
throat, and feel faint or pass out
The most common side effects of ULTOMIRIS in people treated
for PNH are upper respiratory tract infection and headache.
The most common side effects of ULTOMIRIS in people treated
for aHUS are upper respiratory tract infection, diarrhea, nausea,
vomiting, headache, high blood pressure and fever.
The most common side effects of ULTOMIRIS in people with gMG
are diarrhea and upper respiratory tract infections.
The most common side effects of subcutaneous administration
of ULTOMIRIS in adults treated for PNH and aHUS are local injection
site reactions.
Tell your healthcare provider about any side effect that bothers
you or that does not go away. These are not all the possible side
effects of ULTOMIRIS. For more information, ask your healthcare
provider or pharmacist. Call your healthcare provider right away if
you miss an ULTOMIRIS infusion or for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Instructions for Use that comes with subcutaneous
ULTOMIRIS for instructions about the right way to prepare and give
your subcutaneous ULTOMIRIS injections through an on-body
injector.
Please see the accompanying full Prescribing Information and
Medication Guide for ULTOMIRIS, including Boxed WARNING regarding
serious and life-threatening meningococcal infections/sepsis.
Please see the accompanying Instructions for Use for the ULTOMIRIS
On Body Delivery System.
INDICATIONS & IMPORTANT SAFETY INFORMATION FOR SOLIRIS®
(eculizumab) [injection for intravenous use 300mg/30mL
vial]
What is SOLIRIS?
SOLIRIS is a prescription medicine used to treat:
- patients with a disease called Paroxysmal Nocturnal
Hemoglobinuria (PNH).
- adults and children with a disease called atypical Hemolytic
Uremic Syndrome (aHUS). SOLIRIS is not for use in treating people
with Shiga toxin E. coli related hemolytic uremic syndrome
(STEC-HUS).
- adults with a disease called generalized myasthenia gravis
(gMG) who are anti-acetylcholine receptor (AChR) antibody
positive.
- adults with a disease called neuromyelitis optica spectrum
disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody
positive.
It is not known if SOLIRIS is safe and effective in children
with PNH, gMG, or NMOSD.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
SOLIRIS?
SOLIRIS is a medicine that affects your immune system and can
lower the ability of your immune system to fight
infections.
- SOLIRIS increases your chance of getting serious and
life-threatening meningococcal infections that may quickly become
life-threatening and cause death if not recognized and treated
early.
- You must receive meningococcal vaccines at least 2 weeks before
your first dose of SOLIRIS if you are not vaccinated.
- If your doctor decided that urgent treatment with SOLIRIS is
needed, you should receive meningococcal vaccination as soon as
possible.
- If you have not been vaccinated and SOLIRIS therapy must be
initiated immediately, you should also receive 2 weeks of
antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need
additional vaccination. Your doctor will decide if you need
additional vaccination.
- Meningococcal vaccines reduce but do not prevent all
meningococcal infections. Call your doctor or get emergency medical
care right away if you get any of these signs and symptoms of a
meningococcal infection: headache with nausea or vomiting, headache
and fever, headache with a stiff neck or stiff back, fever, fever
and a rash, confusion, muscle aches with flu-like symptoms, and
eyes sensitive to light.
Your doctor will give you a Patient Safety Card about the
risk of meningococcal infection. Carry it with you at all times
during treatment and for 3 months after your last SOLIRIS dose. It
is important to show this card to any doctor or nurse to help them
diagnose and treat you quickly.
SOLIRIS is only available through a program called the
SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must
enroll in the SOLIRIS REMS program; counsel you about the risk of
meningococcal infection; give you information and a Patient
Safety Card about the symptoms and your risk of meningococcal
infection (as discussed above); and make sure that you are
vaccinated with the meningococcal vaccine and, if needed, get
revaccinated with the meningococcal vaccine. Ask your doctor if you
are not sure if you need to be revaccinated.
SOLIRIS may also increase the risk of other types of serious
infections. Make sure your child receives vaccinations against
Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if
treated with SOLIRIS. Certain people may be at risk of serious
infections with gonorrhea. Certain fungal infections (Aspergillus)
may occur if you take SOLIRIS and have a weak immune system or a
low white blood cell count.
Who should not receive SOLIRIS?
Do not receive SOLIRIS if you have a meningococcal infection
or have not been vaccinated against meningitis infection unless
your doctor decides that urgent treatment with SOLIRIS is
needed.
Before you receive SOLIRIS, tell your doctor about all of
your medical conditions, including if you: have an infection or
fever, are pregnant or plan to become pregnant, and are
breastfeeding or plan to breastfeed. It is not known if SOLIRIS
will harm your unborn baby or if it passes into your breast
milk.
Tell your doctor about all the vaccines you receive and
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements which could affect your
treatment. It is important that you have all recommended
vaccinations before you start SOLIRIS, receive 2 weeks of
antibiotics if you immediately start SOLIRIS, and stay up-to-date
with all recommended vaccinations during treatment with
SOLIRIS.
If you have PNH, your doctor will need to monitor you closely
for at least 8 weeks after stopping SOLIRIS. Stopping treatment
with SOLIRIS may cause breakdown of your red blood cells due to
PNH. Symptoms or problems that can happen due to red blood cell
breakdown include: drop in the number of your red blood cell count,
drop in your platelet count, confusion, kidney problems, blood
clots, difficulty breathing, and chest pain.
If you have aHUS, your doctor will need to monitor you
closely during and for at least 12 weeks after stopping treatment
for signs of worsening aHUS symptoms or problems related to
abnormal clotting (thrombotic microangiopathy). Symptoms or
problems that can happen with abnormal clotting may include:
stroke, confusion, seizure, chest pain (angina), difficulty
breathing, kidney problems, swelling in arms or legs, and a drop in
your platelet count.
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious
allergic reactions. Tell your doctor or nurse right away if you
get any of these symptoms during your SOLIRIS infusion: chest pain;
trouble breathing or shortness of breath; swelling of your face,
tongue, or throat; and feel faint or pass out. If you have an
allergic reaction to SOLIRIS, your doctor may need to infuse
SOLIRIS more slowly, or stop SOLIRIS.
The most common side effects in people with PNH treated with
SOLIRIS include: headache, pain or swelling of your nose or
throat (nasopharyngitis), back pain, and nausea.
The most common side effects in people with aHUS treated with
SOLIRIS include: headache, diarrhea, high blood pressure
(hypertension), common cold (upper respiratory infection),
stomach-area (abdominal) pain, vomiting, pain or swelling of your
nose or throat (nasopharyngitis), low red blood cell count
(anemia), cough, swelling of legs or feet (peripheral edema),
nausea, urinary tract infections, and fever.
The most common side effects in people with gMG treated with
SOLIRIS include: muscle and joint (musculoskeletal) pain.
The most common side effects in people with NMOSD treated
with SOLIRIS include: common cold (upper respiratory
infection); pain or swelling of your nose or throat
(nasopharyngitis); diarrhea; back pain; dizziness; flu-like
symptoms (influenza), including fever, headache, tiredness, cough,
sore throat, and body aches; joint pain (arthralgia); throat
irritation (pharyngitis); and bruising (contusion).
Tell your doctor about any side effect that bothers you or that
does not go away. These are not all the possible side effects of
SOLIRIS. For more information, ask your doctor or pharmacist. Call
your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit MedWatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information and Medication
Guide for SOLIRIS, including Boxed WARNING regarding serious and
life-threatening meningococcal infections.
Notes
ULTOMIRIS
ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5
complement inhibitor, offers immediate, complete and sustained
complement inhibition. The medication works by inhibiting the C5
protein in the terminal complement cascade, a part of the body’s
immune system. When activated in an uncontrolled manner, the
complement cascade over-responds, leading the body to attack its
own healthy cells. ULTOMIRIS is administered intravenously every
eight weeks in adult patients, following a loading dose.
ULTOMIRIS is approved in the US, EU and Japan for the treatment
of certain adults with gMG.
ULTOMIRIS is also approved in the US, EU and Japan for the
treatment of certain adults with PNH and for certain children with
PNH in the US and EU.
Additionally, ULTOMIRIS is approved in the US, EU and Japan for
certain adults and children with aHUS to inhibit
complement-mediated thrombotic microangiopathy.
As part of a broad development program, ULTOMIRIS is being
assessed for the treatment of additional hematology and neurology
indications.
SOLIRIS
SOLIRIS (eculizumab) is a first-in-class C5 complement
inhibitor. The medication works by inhibiting the C5 protein in the
terminal complement cascade, a part of the body’s immune system.
When activated in an uncontrolled manner, the terminal complement
cascade over-responds, leading the body to attack its own healthy
cells. SOLIRIS is administered intravenously every two weeks,
following an introductory dosing period.
SOLIRIS is approved in the US, EU and Japan for the treatment of
PNH, aHUS, certain adults with gMG and certain adults with
NMOSD.
SOLIRIS is not indicated for the treatment of patients with
STEC-HUS.
Alexion
Alexion, AstraZeneca Rare Disease, is the group within
AstraZeneca focused on rare diseases, created following the 2021
acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare
diseases for more than 30 years, Alexion is focused on serving
patients and families affected by rare diseases and devastating
conditions through the discovery, development and commercialization
of life-changing medicines. Alexion focuses its research efforts on
novel molecules and targets in the complement cascade and its
development efforts on hematology, nephrology, neurology, metabolic
disorders, cardiology and ophthalmology. Headquartered in Boston,
Massachusetts, Alexion has offices around the globe and serves
patients in more than 50 countries. For more information, please
visit www.alexion.com.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases, and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
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