- Validation initiates formal evaluation of application which started on
August 19, 2021 ; decision expected mid-2022 - If approved, efgartigimod will be the first-and-only approved FcRn antagonist in
Europe - Regulatory reviews of efgartigimod for generalized myasthenia gravis currently underway in the
U.S. ,Japan andEurope
The MAA is supported by results from the pivotal Phase 3 ADAPT trial evaluating the safety and efficacy of efgartigimod for the treatment of patients with gMG.
“gMG is a severe, chronic and debilitating disease that can be unpredictable and greatly impact a person’s quality of life. The EMA’s validation is an exciting step closer to our goal of helping people globally who are living with this disease in which there remains a significant unmet need.” said
“There remains a significant unmet need for new gMG treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” commented Prof. Dr.
Efgartigimod is currently under review with the
Phase 3 ADAPT Trial
The Phase 3 ADAPT trial was a randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of efgartigimod in patients with gMG. A total of 167 adult patients with gMG in
About Efgartigimod
Efgartigimod is an investigational 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.
About Myasthenia Gravis
Myasthenia gravis (MG) is a rare and chronic autoimmune disease, often causing debilitating and potentially life-threatening muscle weakness. More than 85% of people with MG progress to generalized MG (gMG) within 18 months, where muscles throughout the body may be affected, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing and mobility. In more life-threatening cases, MG can affect the muscles responsible for breathing.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. 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 is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in
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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, estimates, anticipates, expects, intends, may, will, or should, and include statements argenx makes concerning: its expected collaboration with European regulatory authorities; its statements regarding therapeutic potential of efgartigimod in patients; the commercial potential of efgartigimod; its clinical development and regulatory plans, including the timing and outcome of regulatory filings and approvals, including those with FDA, PMDA and EMA described in this announcement and the timing and progress of commercialization activities; and its statements regarding research advancements and number of treatment options. 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 the effects of the COVID-19 pandemic, the inherent uncertainties associated with preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s
Source: argenx SE
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