argenx Announces European Commission Approval of Subcutaneous VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis
16 Novembre 2023 - 1:40PM
VYVGART® is now approved for both intravenous
(IV) and self-administered subcutaneous (SC) use in Europe
argenx is committed to continued collaboration
with local authorities across the region to enable broad access to
VYVGART SC for eligible patients
Amsterdam, The Netherlands— November 16,
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
European Commission (EC) approved SC injectable VYVGART
(efgartigimod alfa) as an add-on to standard therapy for the
treatment of generalized myasthenia gravis (gMG) in adult patients
who are anti-acetylcholine receptor (AChR) antibody positive. The
EC previously approved VYVGART IV in August 2022. Following this
decision, VYVGART is now approved in Europe for both IV and
self-administered SC use. The approval is applicable to all 27
European Union (EU) Member States plus Iceland, Norway and
Liechtenstein. argenx will work with local health authorities to
secure patient access for VYVGART SC in the region.
“Today’s approval reflects our commitment to
providing a choice of effective, innovative therapies to people
with autoimmune disease. We are proud to deliver this second
formulation to the European gMG community, just 15 months after the
initial approval of VYVGART IV,” said Anant Murthy, General Manager
of argenx EMEA. “The availability of two formulations, including
the possibility for patients to self-administer at home, allows
people living with gMG to choose the treatment that best works for
their lifestyle, further reinforcing the individualized treatment
approach offered by VYVGART.”
The EC approval follows a positive
recommendation from the Committee for Medicinal Products for Human
Use (CHMP) and is based on positive results from the Phase 3
ADAPT-SC study. ADAPT-SC established the efficacy of VYVGART SC by
demonstrating a reduction in anti-AChR antibody 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 IV in Europe in August 2022.
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 SC
compared with VYVGART IV 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 VYVGART IV or SC 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® SC
VYVGART SC is a SC injectable formulation of
efgartigimod alfa, a human IgG1 antibody fragment marketed for
intravenous use as VYVGART. It is formulated with recombinant human
hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery
technology, to facilitate SC injection delivery of biologics. In
binding to the neonatal Fc receptor (FcRn), VYVGART results in the
reduction of circulating IgG autoantibodies. 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 further information, please
contact:
Media:
Ben PetokBpetok@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 "aims,"
“believes,” “hope,” “estimates,” “anticipates,” “expects,”
“intends,” “may,” “will,” “should,” or "commitment" and include
statements argenx makes concerning the approval by the European
Commission (EC) of SC injectable VYVGART™ (efgartigimod alfa) as an
add-on to standard therapy for the treatment of adult patients with
generalized myasthenia gravis (gMG) who are anti-acetylcholine
receptor (AChR) antibody positive and argenx’s commitment to
collaborating with local authorities across the European Union to
enable broad access to VYVGART for eligible patients for both IV
and self-administered SC use. 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, including but
not limited to argenx’s expectations regarding the inherent
uncertainties associated with development of novel drug therapies,
preclinical and clinical trial and product development activities
and regulatory approval requirements; the acceptance of our
products and product candidates by our patients as safe, effective
and cost-effective, and the impact of governmental laws and
regulations on our business. 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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