- At 48 weeks, 98% of patients treated with
SOLIRIS were relapse free compared to 63% of patients receiving
placebo -
- SOLIRIS is the first and only FDA approved
treatment for this rare, severe, condition that attacks the central
nervous system without warning -
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that
the U.S. Food and Drug Administration (FDA) approved SOLIRIS®
(eculizumab) for the treatment of neuromyelitis optica spectrum
disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4)
antibody positive.1 Approximately three quarters (73%) of all
patients with NMOSD test positive for anti-AQP4 auto-antibodies.2
The FDA approved SOLIRIS following an expedited six-month priority
review. NMOSD is a rare, severe autoimmune disease that attacks the
central nervous system without warning. These attacks, also
referred to as relapses, can cause progressive and irreversible
damage to the brain, optic nerve and spinal cord, which may lead to
long-term disability.3–6 Complement activation due to anti-AQP4
antibodies is one of the primary underlying causes of the
destruction in these patients.3,7 In the PREVENT trial, SOLIRIS, a
first-in-class complement inhibitor, demonstrated safety and
efficacy and met its primary endpoint of prolonging the time to
first adjudicated relapse and reducing the risk of relapse.1,8
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Wire)
“NMOSD is a serious disease with devastating consequences,” said
Michael Levy, M.D., Ph.D., a consultant to the company and
Associate Professor of Neurology at Massachusetts General Hospital
in Boston. “Each attack can result in potentially irreversible
consequences—causing blindness or losing the ability to walk—so
preventing relapse is the primary goal of treatment. With the
approval of SOLIRIS, there is now for the first time an
FDA-approved treatment available to NMOSD patients to help reduce
the risk of relapse.”
NMOSD disproportionately strikes young women in the prime of
their lives, with the average age of first onset at just 39 years.3
Race is also a significant risk factor for disability and mortality
in NMOSD.9–11 In the U.S., African Americans are over-represented
among patients diagnosed with NMOSD and more likely to suffer more
frequent and more severe attacks.9–11 Previously known as Devic’s
Disease, NMOSD is often confused with other neurological illnesses
such as multiple sclerosis (MS), which can lead to delays in
diagnosis and treatment with medicines that can worsen disease
progression.3,12,13
“Today's approval represents an important milestone for the
NMOSD community,” said Victoria Jackson, co-founder of the
Guthy-Jackson Charitable Foundation (GJCF), a non-profit
organization dedicated to funding research and raising awareness
about NMOSD. “We are thrilled to have partnered with industry to
catalyze research and development of targeted therapies to treat
NMOSD. The FDA approval of SOLIRIS is the beginning of a new era
for these NMOSD patients as we continue on our mission to cure this
life-threatening disease.”
This approval is based on comprehensive results from the Phase 3
randomized, double-blind placebo controlled PREVENT trial, which
were recently published in The New England Journal of Medicine. In
the study, patients with NMOSD who were anti-AQP4 antibody positive
were treated with SOLIRIS (n=96) or placebo (n=47). At 48 weeks, 98
percent of patients treated with SOLIRIS were relapse free compared
to 63 percent of patients receiving placebo. This effect was
observed through 144 weeks of treatment, with 96 percent of
patients treated with SOLIRIS relapse free compared to 45 percent
of patients in the placebo arm. SOLIRIS-treated patients
experienced similar improvement in time to first adjudicated
on-trial relapse with or without concomitant treatment. Of the
patients treated solely with SOLIRIS, without receiving other
immunosuppressive therapies (IST), (n=21), 100 percent were relapse
free at 144 weeks compared to 20 percent in the placebo group
(n=13).8
The safety profile of SOLIRIS was consistent with that seen for
SOLIRIS in other clinical studies. The most common adverse events
observed in the PREVENT study were upper respiratory tract
infection (29 percent of patients in the SOLIRIS group vs. 13
percent in the placebo group), nasopharyngitis (21 vs. 19 percent),
diarrhea (16 vs. 15 percent), back pain (15 vs. 13 percent) and
dizziness (15 vs. 13 percent). The serious adverse events that were
reported for more than one patient in either group were pneumonia
(three patients in the SOLIRIS group vs. one patient in the placebo
group) and cellulitis, sepsis and urinary tract infection (two
patients for each event in the SOLIRIS group vs. no patient in the
placebo group). One patient receiving SOLIRIS and concomitant
supportive IST died from infectious pleural effusion. The patient
had an extensive history of pulmonary disease and was an active
smoker. No cases of meningococcal infection were observed in the
study.
“In NMOSD, disease progression is driven by attacks, and so
preventing future relapses is the primary goal of treatment. Today,
for the first time, adults living with anti-AQP4 antibody-positive
NMOSD have an approved treatment to reduce the risk of an
unpredictable relapse – or attack,” said John Orloff, M.D.,
Executive Vice President and Head of Research & Development at
Alexion.
The European Medicines Agency (EMA) and the Japanese Ministry of
Health, Labour and Welfare (MHLW) are reviewing Alexion’s
applications to add the treatment of NMOSD to the marketing
authorizations for SOLIRIS in the European Union (EU) and Japan,
respectively. SOLIRIS has received Orphan Drug Designation (ODD)
for the treatment of patients with NMOSD in the U.S., EU and
Japan.
About NMOSD
NMOSD is a rare and devastating disorder that attacks the
central nervous system (CNS), in which complement activation due to
anti-aquaporin-4 (AQP4) antibodies plays a significant role in the
disease process.3,7 Patients with NMOSD experience unpredictable
attacks, also referred to as relapses, which can cause irreversible
damage to the brain and spinal column— and can lead to long-term
disability.3–6 The most common symptoms of NMOSD are optic neuritis
and transverse myelitis. Transverse myelitis can cause mobility
problems including paralysis; optic neuritis can cause visual
problems including blindness.14,15
Race and gender are risk factors for NMOSD.9–11 The prevalence
of NMOSD may be more common and more severe in non-Caucasian
populations worldwide.9–11 People of African heritage, including
African Americans, are disproportionately affected compared to the
general NMOSD population.9,16 The disease primarily affects women,
often in the prime of their lives, with an average age of onset of
39 years.3
Approximately three quarters (73%) of all patients with NMOSD
have AQP4 auto-antibodies.2 Anti-AQP4 auto-antibody testing is part
of the diagnostic criteria for NMOSD.17 In patients with anti-AQP4
antibody-positive NMOSD, the body’s own immune system can turn
against itself to produce auto-antibodies against AQP4, a protein
on certain cells in the eyes, brain and spinal cord that are
critical for the survival of nerve cells. The binding of these
anti-AQP4 auto-antibodies activates the complement cascade, another
part of the immune system. Complement activation by anti-AQP4
auto-antibodies can cause destruction of vital cells in the CNS,
leading to demyelination and to the death of neurons, predominantly
in the spinal cord and optic nerve.13,18–20
About SOLIRIS® (eculizumab)
SOLIRIS is a first-in-class complement inhibitor that works by
inhibiting the C5 protein in the terminal part of the complement
cascade, a part of the immune system. Activation of the complement
cascade, plays a role in severe rare and ultra-rare disorders like
paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic
uremic syndrome (aHUS), anti-acetylcholine receptor (AchR)
antibody-positive generalized myasthenia gravis (gMG), and
anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica
spectrum disorder (NMOSD). SOLIRIS is approved in the U.S., EU,
Japan and other countries as a treatment for adult patients with
PNH and for adults and children with aHUS. SOLIRIS is not indicated
for the treatment of patients with Shiga-toxin E. coli-related
hemolytic uremic syndrome (STEC-HUS). In the U.S., SOLIRIS is also
approved for the treatment of adult patients with generalized MG
(gMG) who are anti-AchR antibody-positive, in the EU as the first
and only approved treatment of refractory gMG in adults who are
anti-AchR antibody-positive and in Japan for the treatment of
patients with gMG who are AchR antibody-positive and whose symptoms
are difficult to control with high-dose intravenous immunoglobulin
(IVIG) therapy or plasmapheresis (PLEX).
SOLIRIS has received Orphan Drug Designation (ODD) for the
treatment of patients with PNH in the U.S., EU, Japan and many
other countries, for the treatment of patients with aHUS in the
U.S., EU and many other countries, for the treatment of patients
with gMG in the U.S. for the treatment of patients with refractory
gMG in EU and Japan, and for the treatment of NMOSD in the U.S., EU
and Japan. Alexion and SOLIRIS have received some of the
pharmaceutical industry's highest honors for the medical innovation
in complement inhibition: the Prix Galien USA (2008, Best
Biotechnology Product) and France (2009, Rare Disease
Treatment).
INDICATIONS & IMPORTANT SAFETY INFORMATION FOR SOLIRIS®
(eculizumab)
INDICATIONS
What is SOLIRIS?
SOLIRIS is a prescription medicine called a monoclonal antibody.
SOLIRIS is used to treat patients with a disease called Paroxysmal
Nocturnal Hemoglobinuria (PNH). SOLIRIS is used to treat 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). SOLIRIS is
used to treat adults with a disease called generalized myasthenia
gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody
positive. SOLIRIS is used to treat 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
SOLIRIS is a medicine that affects the immune system. SOLIRIS
can lower the ability of the immune system to fight infections.
SOLIRIS increases the chance of getting serious and
life-threatening meningococcal infections. Meningococcal infections
may quickly become life-threatening and cause death if not
recognized and treated early.
Meningococcal vaccines must be received at least two weeks
before the first dose of SOLIRIS if one has not already had this
vaccine. If one’s doctor decided that urgent treatment with SOLIRIS
is needed, meningococcal vaccination should be administered as soon
as possible. If one has not been vaccinated and SOLIRIS therapy
must be initiated immediately, two weeks of antibiotics should also
be administered with the vaccinations. If one had a meningococcal
vaccine in the past, additional vaccination might be needed before
starting SOLIRIS. Patients should ask their doctor if an additional
meningococcal vaccination is needed. Meningococcal vaccines reduce
the risk of meningococcal infection but do not prevent all
meningococcal infections. Call one’s doctor or get emergency
medical care right away if any of these signs and symptoms of a
meningococcal infection occur: 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. One’s doctor will provide a
Patient Safety Card about the risk of meningococcal infection.
Carry the card at all times during treatment and for 3 months after
the last SOLIRIS dose.
SOLIRIS is only available through a program called the
SOLIRIS REMS.
SOLIRIS may also increase the risk of other types of serious
infections. If one’s child is treated with SOLIRIS, make sure that
the child receives vaccinations against Streptococcus pneumoniae
and Haemophilus influenzae type b (Hib). Certain people may be at
risk of serious infections with gonorrhea. Talk to the doctor about
whether one is at risk for gonorrhea infection, about gonorrhea
prevention, and regular testing. Certain fungal infections
(Aspergillus) may also happen if one takes SOLIRIS and has a weak
immune system or a low white blood cell count.
Do not receive SOLIRIS if one has a meningococcal infection, or
has not been vaccinated against meningitis infection unless one’s
doctor decides that urgent treatment with SOLIRIS is needed.
Before one receives SOLIRIS, tell the doctor about all of the
medical conditions, including if one: has an infection or fever, is
pregnant or plans to become pregnant, and is breastfeeding or plans
to breastfeed. It is not known if SOLIRIS will harm an unborn baby
or if SOLIRIS passes into the breast milk.
Tell the doctor about all the medicines one takes, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. SOLIRIS and other medicines can affect each other,
causing side effects.
It is important that one: has all recommended vaccinations
before starting SOLIRIS, receives 2 weeks of antibiotics if one
immediately starts SOLIRIS, and stays up-to-date with all
recommended vaccinations during treatment with SOLIRIS. Know the
medications one takes and the vaccines one receives. Keep a list of
them to show the doctor and pharmacist when one gets a new
medicine.
If one has PNH, the doctor will need to monitor closely for at
least 8 weeks after stopping SOLIRIS. Stopping treatment with
SOLIRIS may cause breakdown of the red blood cells due to PNH.
Symptoms or problems that can happen due to red blood cell
breakdown include: drop in the number of the red blood cell count,
drop in the platelet counts, confusion, kidney problems, blood
clots, difficulty breathing, and chest pain. If one has aHUS, the
doctor will need to monitor 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, swellings in
arms or legs, and a drop in the platelet count.
SOLIRIS can cause serious side effects including serious
allergic reactions. Serious allergic reactions can happen during
one’s SOLIRIS infusion. Tell the doctor or nurse right away if one
gets any of these symptoms during the SOLIRIS infusion: chest pain,
trouble breathing or shortness of breath, swelling of the face,
tongue, or throat, and feeling faint or pass out. If one has an
allergic reaction to SOLIRIS, the 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 the 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 the 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 the 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).
Please see the accompanying full Prescribing
Information and Medication Guide for SOLIRIS, including
BOXED WARNING regarding serious and life-threatening meningococcal
infections.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases through the
discovery, development and commercialization of life-changing
therapies. As the global leader in complement biology and
inhibition for more than 20 years, Alexion has developed and
commercializes two approved complement inhibitors to treat patients
with paroxysmal nocturnal hemoglobinuria (PNH), as well as the
first and only approved complement inhibitor to treat atypical
hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor
(AchR) antibody-positive generalized myasthenia gravis (gMG) and
anti-AQP4 antibody-positive neuromyelitis optica spectrum disorder
(NMOSD). Alexion also has two highly innovative enzyme replacement
therapies for patients with life-threatening and ultra-rare
metabolic disorders, hypophosphatasia (HPP) and lysosomal acid
lipase deficiency (LAL-D). In addition, the company is developing
several mid-to-late-stage therapies, including a second complement
inhibitor, a copper-binding agent for Wilson disease and an
anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G
(IgG)-mediated diseases as well as several early-stage therapies,
including one for light chain (AL) amyloidosis and a second
anti-FcRn therapy. Alexion focuses its research efforts on novel
molecules and targets in the complement cascade and its development
efforts on the core therapeutic areas of hematology, nephrology,
neurology and metabolic disorders. Alexion has been named to the
Forbes’ list of the World’s Most Innovative Companies seven years
in a row and is headquartered in Boston, Massachusetts’ Innovation
District. The company also has offices around the globe and serves
patients in more than 50 countries. This press release and further
information about Alexion can be found at: www.alexion.com.
[ALXN-G]
Forward-Looking Statement
This press release contains forward-looking statements,
including statements related to: the consequences of NMOSD attacks
and relapses; the primary goal of treatment for patients with
NMOSD; and the potential benefits of SOLIRIS as a treatment for
patients with NMOSD. Forward-looking statements are subject to
factors that may cause Alexion's results and plans to differ
materially from those forward-looking statements, including for
example: results in clinical trials may not be indicative of
results from later stage or larger clinical trials (or in broader
patient populations once the product is approved for use by
regulatory agencies); the possibility that results of clinical
trials are not predictive of safety and efficacy and potency of our
products (or we fail to adequately operate or manage our clinical
trials) which could cause us to discontinue sales of the product
(or halt trials, delay or prevent us from making regulatory
approval filings or result in denial of approval of our product
candidates); unexpected delays in clinical trials; unexpected
concerns regarding products and product candidates that may arise
from additional data or analysis obtained during clinical trials or
obtained once used by patients following product approval; future
product improvements may not be realized due to expense or
feasibility or other factors; delays (expected or unexpected) in
the time it takes regulatory agencies to review and make
determinations on applications for the marketing approval of our
products; inability to timely submit (or failure to submit) future
applications for regulatory approval for our products and product
candidates; inability to timely initiate (or failure to initiate)
and complete future clinical trials due to safety issues, IRB
decisions, CMC-related issues, expense or unfavorable results from
earlier trials (among other reasons); our dependence on sales from
our principal product (Soliris); future competition from
biosimilars and novel products; decisions of regulatory authorities
regarding the adequacy of our research, marketing approval or
material limitations on the marketing of our products; delays or
failure of product candidates to obtain regulatory approval; delays
or the inability to launch product candidates due to regulatory
restrictions, anticipated expense or other matters; interruptions
or failures in the manufacture and supply of our products and our
product candidates; failure to satisfactorily address matters
raised by the FDA and other regulatory agencies regarding products
and product candidates; uncertainty of long-term success in
developing, licensing or acquiring other product candidates or
additional indications for existing products; inability to complete
acquisitions or grow the product pipeline through acquisitions
(including due to failure to obtain antitrust approvals); the
possibility that current rates of adoption of our products are not
sustained; the adequacy of our pharmacovigilance and drug safety
reporting processes; failure to protect and enforce our data,
intellectual property and proprietary rights and the risks and
uncertainties relating to intellectual property claims, lawsuits
and challenges against us (including intellectual property lawsuits
relating to Ultomiris brought by third parties and inter partes
review petitions submitted by third parties); the risk that third
party payors (including governmental agencies) will not reimburse
or continue to reimburse for the use of our products at acceptable
rates or at all; failure to realize the benefits and potential of
investments, collaborations, licenses and acquisitions; the
possibility that expected tax benefits will not be realized;
potential declines in sovereign credit ratings or sovereign
defaults in countries where we sell our products; delay of
collection or reduction in reimbursement due to adverse economic
conditions or changes in government and private insurer regulations
and approaches to reimbursement; uncertainties surrounding legal
proceedings, company investigations and government investigations,
including investigations of Alexion by the U.S. Securities and
Exchange Commission (SEC) and U.S. Department of Justice; the risk
that estimates regarding the number of patients with PNH, aHUS,
gMG, HPP and LAL-D and other indications we are pursuing are
inaccurate; the risks of changing foreign exchange rates; risks
relating to the potential effects of the Company's restructuring;
risks related to the acquisition of Syntimmune and other companies
and co-development efforts; and a variety of other risks set forth
from time to time in Alexion's filings with the SEC, including but
not limited to the risks discussed in Alexion's Quarterly Report on
Form 10-Q for the quarter ended March 31, 2019 and in our other
filings with the SEC. Alexion disclaims any obligation to update
any of these forward-looking statements to reflect events or
circumstances after the date hereof, except when a duty arises
under law.
References
1 SOLIRIS® Product Information.
2 Hamid SHM, Whittam D, Mutch K, et al. What proportion of
AQP4-IgG-negative NMO spectrum disorder patients are MOG-IgG
positive? A cross sectional study of 132 patients. J Neurol.
2017;264(10):2088-2094.
3 Wingerchuk DM, Lennon VA, Lucchinetti CF, Pittock SJ,
Weinshenker BG. The spectrum of neuromyelitis optica. Lancet
Neurol. 2007;6(9):805-815.
4 Wingerchuk DM. Diagnosis and Treatment of Neuromyelitis
Optica. Neurologist. 2007;13(1):2-11.
5 Wingerchuk DM, Weinshenker BG. Neuromyelitis optica. Curr
Treat Options Neurol. 2008;10(1):55-66.
6 Kitley J, Leite MI, Nakashima I, et al. Prognostic factors and
disease course in aquaporin-4 antibody-positive patients with
neuromyelitis optica spectrum disorder from the United Kingdom and
Japan. Brain. 2012;135(6):1834-1849.
7 Papadopoulos MC, Verkman AS. Aquaporin water channels in the
nervous system. Nat Rev Neurosci. 2013;14(4):265.
8 Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in
Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N Engl
J Med. 2019.
9 Flanagan EP, Cabre P, Weinshenker BG, et al. Epidemiology of
aquaporin‐4 autoimmunity and neuromyelitis optica spectrum. Ann
Neurol. 2016;79(5):775-783.
10 Kim S-H, Mealy MA, Levy M, et al. Racial differences in
neuromyelitis optica spectrum disorder. Neurology.
2018;91(22):e2089-e2099.
11 Mealy MA, Kessler RA, Rimler Z, et al. Mortality in
neuromyelitis optica is strongly associated with African ancestry.
Neurol Neuroinflammation. 2018;5(4):e468.
12 Jarius S, Ruprecht K, Wildemann B, et al. Contrasting disease
patterns in seropositive and seronegative neuromyelitis optica: a
multicentre study of 175 patients. J Neuroinflammation.
2012;9(1):14.
13 Papadopoulos MC, Bennett JL, Verkman AS. Treatment of
neuromyelitis optica: state-of-the-art and emerging therapies. Nat
Rev Neurol. 2014;10(9):493.
14 Mutch K, Methley A, Moore P, Jacob A. Life on hold: the
experience of living with neuromyelitis optica. Disabil Rehabil.
2014;36(13):1100-1107.
15 Hinson SR, Lennon VA, Pittock SJ. Autoimmune AQP4
channelopathies and neuromyelitis optica spectrum disorders. In:
Handbook of Clinical Neurology. Vol 133. Elsevier;
2016:377-403.
16 Cabrera-Gómez JA, Kurtzke JF, González-Quevedo A,
Lara-Rodriguez R. An epidemiological study of neuromyelitis optica
in Cuba. J Neurol. 2009;256(1):35-44.
17 Bennett JL. Finding NMO: The Evolving Diagnostic Criteria of
Neuromyelitis Optica. J Neuroophthalmol. 2016;36(3):238.
18 Hinson SR, Romero MF, Popescu BFG, et al. Molecular outcomes
of neuromyelitis optica (NMO)-IgG binding to aquaporin-4 in
astrocytes. Proc Natl Acad Sci. 2012;109(4):1245-1250.
19 Hinson SR, Pittock SJ, Lucchinetti CF, et al. Pathogenic
potential of IgG binding to water channel extracellular domain in
neuromyelitis optica. Neurology. 2007;69(24):2221-2231.
20 Verkman AS. Aquaporins in clinical medicine. Annu Rev Med.
2012;63:303-316.
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Media Megan Goulart Senior Director, Corporate
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