Results from CHAMPION-NMOSD trial
demonstrated zero relapses with a median treatment duration of 73
weeks
Additional presentations will underscore
debilitating emotional and physical toll of NMOSD on patients and
caregivers, and highlight urgency to reduce disease burden
Alexion, AstraZeneca Rare Disease, will present new data showing
significant advances for the treatment of anti-aquaporin-4 (AQP4)
antibody-positive (Ab+) neuromyelitis optica spectrum disorder
(NMOSD) at the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) Congress, October 26 to 28, 2022.
Data presented at the meeting will feature new insights from
Alexion’s complement portfolio illustrating the critical role of C5
inhibition in treating AQP4 Ab+ NMOSD and significantly reducing
the risk of relapses, including findings on the first and only
long-acting C5 complement inhibitor, ULTOMIRIS®
(ravulizumab-cwvz).
Marc Dunoyer, Chief Executive Officer, Alexion, said: “NMOSD
relapses are unpredictable and often cause permanent disability,
including blindness, paralysis and even premature death. Our data
build on the established role of complement inhibition in managing
NMOSD and reinforce our commitment to patient-centered innovation.
Results from the CHAMPION-NMOSD trial highlight the potential for
ULTOMIRIS to substantially reduce the risk of relapse and ease
treatment burden for the community.”
Redefining NMOSD disease management
An oral presentation will showcase results of the CHAMPION-NMOSD
trial, which evaluated the safety and efficacy of ULTOMIRIS in
adults with AQP4 Ab+ NMOSD, compared to the external placebo arm
from the pivotal SOLIRIS® PREVENT clinical trial.
The data will show there were zero adjudicated on-trial relapses
observed in patients with AQP4 Ab+ NMOSD with a median treatment
duration of 73 weeks, representing a relapse risk reduction of
98.6% (p<0.0001) compared to the external placebo arm. The
safety and tolerability of ULTOMIRIS in the CHAMPION-NMOSD trial
were consistent with previous clinical studies and other approved
indications.
Improving understanding of the NMOSD patient
experience
Two poster presentations detail findings from qualitative
interviews with NMOSD patients. This work helps to inform the
scientific community about the immediate and lasting impact of
relapses, including ability to work and participate in daily
activities, mobility and pain as well as reliance on caregiver
support.
Alexion presentations during ECTRIMS 2022
Lead author
Abstract title
Presentation details
Pittock, SJ
Efficacy and safety of ravulizumab-cwvz in
adults with anti-aquaporin-4 antibody-positive neuromyelitis optica
spectrum disorder: outcomes from the phase 3 CHAMPION-NMOSD
trial
Oral Presentation O051
October 27, 2022
10:05 CEST (4:05 EDT)
Pittock, SJ
Efficacy subgroup analyzes from the phase
3 CHAMPION-NMOSD trial in adults with anti-aquaporin-4
antibody-positive neuromyelitis optica spectrum disorder
Poster Presentation P010
October 26, 2022
16:30 CEST (10:30 EDT)
ePoster Tour 5
October 28, 2022
14:00 CEST (8:00 EDT)
Allen, K
Sensitivity analysis using propensity
score methods for primary efficacy outcome in the CHAMPION-NMOSD
trial
Poster Presentation P012
October 26, 2022
16:30 CEST (10:30 EDT)
Palace, J
Mortality estimates in patients with
anti-aquaporin-4 autoantibody positive neuromyelitis optica
spectrum disorder
Poster Presentation P018
October 26, 2022
16:30 CEST (10:30 EDT)
Kielhorn, A
Long-term burden of relapse in patients
with AQP4+ NMOSD: simulation study based on network
meta-analysis
Poster Presentation P019
October 26, 2022
16:30 CEST (10:30 EDT)
Osborne, B
Activity impairment and support needs in
patients with neuromyelitis optica spectrum disorder
Poster Presentation P418
October 27, 2022
17:00 CEST (11:00 EDT)
Bernitsas, E
Understanding the symptoms of patients
with neuromyelitis optica spectrum disorder and their impact on
patient’s lives: a qualitative interview study
ePoster Presentation EP0901
October 26, 2022
8:00 CEST (2:00 EDT)
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.
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 doctor 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 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 8 months after your last ULTOMIRIS dose.
It is important to show this card to any doctor 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 doctor
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 doctor 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 Haemophilis influenzae type b
(Hib) if treated with ULTOMIRIS. Call your doctor 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 doctor decides that urgent treatment with
ULTOMIRIS is needed.
Before you receive ULTOMIRIS, 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 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 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.
If you have PNH and you stop receiving ULTOMIRIS, your doctor
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 doctor 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, or bad taste. Tell
your doctor 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 with 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 infection.
The most common side effects of subcutaneous administration
of ULTOMIRIS in adults treated for PNH and aHUS are local injection
site reactions.
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
ULTOMIRIS. For more information, ask your doctor or pharmacist.
Call your doctor 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.
Notes
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 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. Please visit
www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221011006006/en/
Media Inquiries Todd Siesky +1 475 434 8140 Alexion Media
Mailbox: media@alexion.com
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