argenx Announces the UK MHRA has Granted Early Access to Efgartigimod for Generalized Myasthenia Gravis
May 31 2022 - 1:00AM
Positive
scientific opinion under Early Access to Medicines Scheme (EAMS)
will make efgartigimod available to eligible generalized myasthenia
gravis (gMG) patients in the UK prior to marketing
authorization
Efgartigimod was granted a Promising Innovative
Medicine (PIM) designation by UK’s Medicines and Healthcare
products Regulatory Agency (MHRA) in November 2021
Breda, the
Netherlands—May
31, 2022—argenx
SE (Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today announced that efgartigimod, the
Company’s neonatal Fc receptor (FcRn) blocker has been awarded a
positive scientific opinion by the MHRA under the EAMS. Within the
EAMS, efgartigimod is indicated for the treatment of adult patients
with anti-acetylcholine receptor (AChR) antibody seropositive gMG,
including patients with refractory gMG who have failed, not
tolerated or are ineligible for licensed treatment.
The EAMS program offers early access to
innovative medicines for patients who are experiencing a
significant unmet medical need, before the MHRA approves a formal
marketing authorization application (MAA) and prior to
reimbursement. The positive scientific opinion enables healthcare
providers to decide whether to prescribe a treatment before
licensing is approved, granting eligible gMG patients in the UK the
potential for early, pre-license access to efgartigimod while
relevant regulatory bodies complete the review of the MAA.
“Despite currently available treatments, gMG
patients in the UK face a significant disease burden and many
struggle to manage the debilitating symptoms of this rare
autoimmune disease. We are committed to addressing this unmet need,
and are thrilled that UK healthcare professionals now have a
potential new option for the treatment of their eligible gMG
patients,” said David Knechtel, UK Country Manager at argenx. “The
MHRA’s positive scientific opinion supports our belief in the value
efgartigimod can offer to people living with gMG, and marks another
advancement toward our goal of serving patients around the world.
We look forward to continued collaboration with the agency to make
this innovative therapy available to UK patients as soon as
possible.”
The European Medicines Agency (EMA) is currently
reviewing the MAA for efgartigimod for the treatment of gMG, with a
decision expected in the second half of 2022, followed by an
anticipated decision from the MHRA on a UK marketing authorization.
Efgartigimod was previously granted a PIM designation by the MHRA
in November 2021.
About
Generalized
Myasthenia Gravis Generalized myasthenia
gravis (gMG) is a rare and chronic autoimmune disease, impacting up
to 15,000 UK patients, where immunoglobulin G (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
months1, where muscles throughout the body may be affected.
Patients with confirmed AChR antibodies account for approximately
85% of the total gMG population1.
About EfgartigimodEfgartigimod
is an antibody fragment designed to reduce pathogenic
immunoglobulin G (IgG) antibodies by binding to the neonatal Fc
receptor and blocking the IgG recycling process. Efgartigimod is
being investigated in several autoimmune diseases known to be
mediated by disease-causing IgG antibodies, including neuromuscular
disorders, blood disorders, and skin blistering diseases. It is
currently approved in the United States for the treatment of adult
patients with gMG who are anti-acetylcholine receptor antibody
positive, and Japan for adult patients with gMG who do not have
sufficient response to steroids or non-steroidal immunosuppressive
therapies.
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. and Japan.
References
- Behin et al. New Pathways and Therapeutics Targets in
Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018.
265-277
For further information, please
contact: Media:Kelsey
Kirkkkirk@argenx.com
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Michelle Greenblattmgreenblatt@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 future availability of
efgartigimod for the treatment of adult patients with AChR-antibody
seropositive gMG and the timing of any approval or marketing
authorization by the EMA and the UK of the use of efgartigimod for
the treatment of gMG. 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 to 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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