argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis
18 Janvier 2024 - 7:00AM
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Availability of VYVGART® and self-administered VYVDURA demonstrates
continued commitment to providing more choice and flexibility for
gMG patients in Japan
Jan. 18, 2024, 7:00 AM CET
Amsterdam, the Netherlands –
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced that Japan’s Ministry
of Health, Labour and Welfare (MHLW) approved VYVDURA®
(efgartigimod alfa and hyaluronidase-qvfc) injection for
subcutaneous (SC) use for the treatment of adult patients with
generalized myasthenia gravis (gMG), who do not have sufficient
response to steroids or non-steroidal immunosuppressive therapies
(ISTs). Following this decision, VYVGART is now approved in Japan
for both intravenous (IV) and self-administered SC use.
“Today’s approval of VYVDURA marks a significant
milestone for the gMG community in Japan and furthers our
commitment to deliver innovative treatments to autoimmune patients
globally,” said Hermann Strenger, General Manager, argenx Japan.
“Bringing VYVDURA to Japan means there are now two formulations
available for gMG patients, including the possibility to
self-inject at home, allowing patients and their healthcare
providers to choose the best option to meet their treatment
needs.”
The approval of VYVDURA is based on positive
results from the Phase 3 ADAPT-SC study. ADAPT-SC established the
efficacy of VYVDURA by demonstrating a reduction in percent change
from baseline in total immunoglobulin G (IgG) levels comparable to
VYVGART IV in adult gMG patients. ADAPT-SC was a bridging study to
the Phase 3 ADAPT study, which formed the basis for approval of
VYVGART in Japan in January 2022.
About the 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 VYVDURA
compared with VYVGART in adult patients with gMG. The
pharmacodynamic effect was measured by percent change from baseline
for both total IgG and AChR autoantibody 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 VYVDURA 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 VYVDURA®
VYVDURA 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), VYVDURA results in the
reduction of circulating IgG. VYVGART SC was approved in the United
States in June 2023 and is marketed as VYVGART® Hytrulo.
About Generalized Myasthenia
Gravis
Generalized 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 approved neonatal Fc receptor (FcRn) blocker in the U.S.,
Japan, Israel, the EU, the UK, Canada and China. 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:
Ben PetokBPetok@argenx.com
Investors:
Alexandra Roy (US)ARoy@argenx.com
Lynn Elton (EU)LElton@argenx.com
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