- VYVGART® Hytrulo is first
FDA-approved subcutaneous (SC) injectable for generalized
myasthenia gravis (gMG)
- With this approval, argenx broadens
innovative gMG product offering and demonstrates continued
commitment to providing more choice and flexibility for
patients
- Efficacy of VYVGART Hytrulo was
established by demonstrating a comparable pharmacodynamic (PD)
effect to VYVGART® in Phase 3 ADAPT-SC bridging study
- Management to host conference call
tomorrow at 2:30pm CET (8:30 am ET)
Regulated Information/Inside
Information
Amsterdam, the
Netherlands—June 20,
2023—argenx SE (Euronext & Nasdaq:
ARGX), a global immunology company committed to improving the lives
of people suffering from severe autoimmune diseases, today
announced that the U.S. Food and Drug Administration (FDA) approved
VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc).
VYVGART Hytrulo is an injection for subcutaneous (SC) use for the
treatment of generalized myasthenia gravis (gMG) in adult patients
who are anti-acetylcholine receptor (AChR) antibody positive. These
patients represent approximately 85% of the total gMG
population.
VYVGART Hytrulo is a subcutaneous product
combination of efgartigimod alfa, a human IgG1 antibody fragment
marketed for intravenous use as VYVGART, and recombinant human
hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery
technology to facilitate subcutaneous delivery of biologics. The
product is to be administered subcutaneously by a healthcare
professional as a single injection (1,008 mg fixed dose) over 30-90
seconds in cycles of once weekly injections for four weeks.
“Today’s approval of VYVGART Hytrulo is another
significant milestone on our path to redefine what well-controlled
means for gMG patients. The availability of a second argenx
innovation in just 18 months also underscores our longstanding
commitment to the gMG community by providing more choice and
flexibility in how patients receive treatment,” said Luc Truyen
M.D., Ph.D., Chief Medical Officer, argenx. “With our broad gMG
offering of both a first-in-class infusion and SC injection, we
continue to offer an individualized treatment approach and
possibility of staying symptom free, while providing patients
options of how and where they want to seek treatment. We want to
thank the gMG patient community and their supporters, clinical
investigators, our employees and all stakeholders who have
collaborated with us to advance this subcutaneous option, including
our partners at Halozyme.”
“The availability of another gMG treatment
option from argenx, now in a subcutaneous delivery, is a meaningful
advancement for the patient community. Patients now have the
opportunity to receive treatment in an infusion center, at home or
at a physician’s office - providing more flexibility and freedom of
choice that can make daily living easier for gMG patients and their
caregivers,” said Allison Foss, Executive Director of the
Myasthenia Gravis Association.
Phase 3
ADAPT-SC Bridging
Study
“The clinical trials of VYVGART continue to show
significant benefit to patients with a favorable safety profile and
clear improvements in gMG disease scores. Now with the approval of
VYVGART Hytrulo, we have a broad gMG treatment offering with both
IV and SC administration options and can select based on patient
needs and preference without sacrificing clinical benefit or
safety,” said James F. Howard Jr., M.D., Professor of Neurology
(Neuromuscular Disease), Medicine and Allied Health, Department of
Neurology, The University of North Carolina at Chapel Hill School
of Medicine and Principal Investigator for the ADAPT-SC trial.
This FDA approval is based on positive results
from the Phase 3 ADAPT-SC study, which established the efficacy of
VYVGART Hytrulo by demonstrating a reduction in anti-AChR antibody
levels comparable to intravenous VYVGART in adult gMG patients.
ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which
formed the basis for approval of intravenous VYVGART in December
2021.
In the ADAPT-SC study, the primary endpoint of
noninferiority was met (p< 0.0001) and VYVGART Hytrulo
demonstrated mean total IgG reduction of 66.4% from baseline at day
29, compared to 62.2% with VYVGART. Additional key secondary
endpoints were met, which were consistent with efficacy measures
from the ADAPT study identifying the correlation between total IgG
reduction and clinical benefit in gMG.
VYVGART Hytrulo has a demonstrated safety
profile, consistent with the ADAPT clinical trial with the
exception of injection site reactions (ISRs), which were higher
with VYVGART Hytrulo. It was generally well-tolerated with ISRs
being the most frequent adverse events. All ISRs, which are
commonly observed with biologics administered subcutaneously, were
mild to moderate, and resolved over time.
Access
to VYVGART Hytrulo
VYVGART Hytrulo is expected to be available for
patients in the U.S. in July 2023. argenx is committed to
supporting access for patients to its medicines and has decided to
price VYVGART Hytrulo at parity to VYVGART on a net annual revenue
basis.
Throughout their treatment journey, patients can
access VYVGART Hytrulo in the same personalized way they access
VYVGART today with support from My VYVGART Path. Program resources
include disease and product education, access support and benefits
verification, and financial assistance programs for eligible
patients. Patients and clinicians can access more information at
VYVGARTHytrulo.com.
Marketing authorization applications for SC
efgartigimod are under review by the European Medicines Agency with
a decision expected by the end of 2023, and Japan’s Pharmaceuticals
and Medical Devices Agency (PMDA) with a decision expected by the
first quarter of 2024.
Conference Call
Detailsargenx will host a conference call
tomorrow, June 21, 2023, at 2:30 pm CET (8:30am ET) to discuss the
approval. A webcast of the live call and replay may be accessed on
the Investors section of the argenx website.
Dial-in numbers:Please dial in
15 minutes prior to the live call.
Belgium 32
800 50
201France 33
800
943355Netherlands 31
20 795 1090United
Kingdom 44 800 358
0970United States
1
888 415
4250Japan 81
3 4578
9752Switzerland 41
43 210 11 32
See Important Safety Information below and full
Prescribing Information for VYVGART Hytrulo for additional
information.
Important Safety
Information
What is VYVGART® HYTRULO (efgartigimod
alfa and
hyaluronidase-qvfc)?VYVGART
HYTRULO is a prescription medicine used to treat a condition called
generalized myasthenia gravis, which causes muscles to tire and
weaken easily throughout the body, in adults who are positive for
antibodies directed toward a protein called acetylcholine receptor
(anti-AChR antibody positive).
IMPORTANT SAFETY
INFORMATION
What is the most important information I
should know about VYVGART HYTRULO?VYVGART HYTRULO may
cause serious side effects, including:
- Infection. VYVGART
HYTRULO may increase the risk of infection. The most common
infections for efgartigimod alfa-fcab-treated patients were urinary
tract and respiratory tract infections. More patients on
efgartigimod alfa-fcab vs placebo had below normal levels for white
blood cell counts, lymphocyte counts, and neutrophil counts. The
majority of infections and observed lower white blood cell counts
were mild to moderate in severity. Your healthcare provider should
check you for infections before starting treatment, during
treatment, and after treatment with VYVGART HYTRULO. Tell your
healthcare provider if you have any history of infections. Tell
your healthcare provider right away if you have signs or symptoms
of an infection during treatment with VYVGART HYTRULO such as
fever, chills, frequent and/or painful urination, cough, pain and
blockage of nasal passages/sinus, wheezing, shortness of breath,
fatigue, sore throat, excess phlegm, nasal discharge, back pain,
and/or chest pain. If a serious infection occurs, your doctor will
treat your infection and may even stop your VYVGART HYTRULO
treatment until the infection has resolved.
- Undesirable immune
reactions (hypersensitivity reactions). VYVGART HYTRULO
and efgartigimod alfa-fcab can cause the immune system to have
undesirable reactions such as rashes, swelling under the skin, and
shortness of breath. Hives were also observed in patients treated
with VYVGART HYTRULO. In clinical studies, the reactions were mild
or moderate and occurred within 1 hour to 3 weeks of
administration, and the reactions did not lead to VYVGART HYTRULO
discontinuation. Your healthcare provider should monitor you during
and after treatment and discontinue VYVGART HYTRULO if needed. Tell
your healthcare provider immediately about any undesirable
reactions to VYVGART HYTRULO.
Before taking VYVGART HYTRULO, tell your
healthcare provider about all of your medical conditions, including
if you:
- Have a history of infection or you
think you have an infection.
- Have received or are scheduled to
receive a vaccine (immunization). Discuss with your healthcare
provider whether you need to receive age-appropriate immunizations
before initiation of a new treatment cycle with VYVGART HYTRULO.
The use of vaccines during VYVGART HYTRULO treatment has not been
studied, and the safety with live or live-attenuated vaccines is
unknown. Administration of live or live-attenuated vaccines is not
recommended during treatment with VYVGART HYTRULO.
- Are pregnant or plan to become
pregnant and are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
What are the common side effects of
VYVGART HYTRULO?The most common side effects of
efgartigimod alfa-fcab-treated patients were respiratory tract
infection, headache, and urinary tract infection. Additional common
side effects of VYVGART HYTRULO are injection site reactions,
including rash, redness of the skin, itching sensation, bruising,
pain, and hives.These are not all the possible side effects of
VYVGART HYTRULO. Call your doctor for medical advice about side
effects. You may report side effects to the US Food and Drug
Administration at 1-800-FDA-1088.
Please see the full Prescribing
Information for VYVGART HYTRULO and talk to your
doctor.
About Phase 3 ADAPT-SC
Trial
The Phase 3 ADAPT-SC trial was a multicenter,
randomized, open-label, parallel-group study evaluating the
noninferiority of the pharmacodynamic (PD) effect of VYVGART
Hytrulo compared with VYVGART in adult patients with gMG. The
pharmacodynamic effect was measured by percent change from baseline
in autoantibody (AChR) levels at day 29. Safety, clinical efficacy,
immunogenicity and pharmacokinetics (PK) were also assessed. A
total of 110 adult patients with gMG in North America, Europe and
Japan enrolled in the ADAPT-SC trial. Patients were randomized in a
1:1 ratio to receive VYVGART Hytrulo or VYVGART for one treatment
cycle consisting of four doses at once-weekly intervals. The total
study duration was approximately 12 weeks, including seven weeks of
follow-up after the treatment cycle. At the completion of ADAPT-SC,
patients had the opportunity to roll-over to ADAPT-SC+, an
open-label extension study.
About
VYVGART®
Hytrulo
VYVGART Hytrulo is a subcutaneous combination of
efgartigimod alfa, a human IgG1 antibody fragment marketed for
intravenous use as VYVGART®, and recombinant human hyaluronidase
PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to
facilitate subcutaneous injection delivery of biologics. In binding
to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the
reduction of circulating IgG. It is the first-and-only approved
FcRn blocker administered by subcutaneous injection.
About Generalized Myasthenia
GravisGeneralized myasthenia gravis (gMG) is a rare and
chronic autoimmune disease where IgG autoantibodies disrupt
communication between nerves and muscles, causing debilitating and
potentially life-threatening muscle weakness. Approximately 85% of
people with MG progress to gMG within 24 months, where muscles
throughout the body may be affected. Patients with confirmed AChR
antibodies account for approximately 85% of the total gMG
population.
About argenx
argenx is a global immunology company committed
to improving the lives of people suffering from severe autoimmune
diseases. Partnering with leading academic researchers through its
Immunology Innovation Program (IIP), argenx aims to translate
immunology breakthroughs into a world-class portfolio of novel
antibody-based medicines. argenx developed and is commercializing
the first-and-only approved neonatal Fc receptor (FcRn) blocker in
the U.S., Japan, Israel, the EU and the UK. The Company is
evaluating efgartigimod in multiple serious autoimmune diseases and
advancing several earlier stage experimental medicines within its
therapeutic franchises. For more information, visit www.argenx.com
and follow us on LinkedIn, Twitter, and Instagram.
For further information, please
contact:
Media:Erin MurphyEMurphy@argenx.com
Investors:Alexandra Roy
(US)ARoy@argenx.com
Lynn Elton (EU)LElton@argenx.com
Forward-looking Statements The contents of this
announcement include statements that are, or may be deemed to be,
“forward-looking statements.” These forward-looking statements can
be identified by the use of forward-looking terminology, including
the terms “believes,” “hope,” “estimates,” “anticipates,”
“expects,” “intends,” “may,” “will,” or “should” and include
statements argenx makes concerning the benefits and safety profile
of VYVGART; the expected availability of VYVGART Hytrulo; and the
timing and outcome of marketing authorizations for VYVGART Hytrulo
by the European Medicines Agency and Japan’s Pharmaceuticals and
Medical Devices Agency. By their nature, forward-looking statements
involve risks and uncertainties and readers are cautioned that any
such forward-looking statements are not guarantees of future
performance. argenx’s actual results may differ materially from
those predicted by the forward-looking statements as a result of
various important factors. A further list and description of these
risks, uncertainties and other risks can be found in argenx’s U.S.
Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed
with the SEC as well as subsequent filings and reports filed by
argenx with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation publicly update or revise the information in this press
release, including any forward-looking statements, except as may be
required by law.
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- VYVGART Hytrulo Logo
- Tim Van Hauwermeiren
- argenx
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