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▎The content team editor of WuXi AppTec recently, argenx announced that the US FDA has approved the "first-in-class" therapy Vyvgart (efgartigimod alfa-fcab) for the treatment of anti-acetylcholine receptor (AChR) antibody-positive systemic myasthenia gravis (GMG) Adult patients
.
These patients account for approximately 85% of all gMG patient populations
.
The press release states that Vyvgart is the first FDA-approved neonatal Fc receptor (FcRn) blocker
.
Myasthenia gravis is a rare chronic autoimmune disease
.
Immunoglobulin G (IgG) antibodies disrupt the communication between nerves and muscles, causing weakness and possibly life-threatening muscle weakness
.
More than 85% of patients progress to generalized myasthenia gravis within 18 months after the onset of the disease, which leads to extreme fatigue and difficulty in facial expressions, speech, swallowing, and movement
.
Vyvgart is a "first-in-class" therapy targeting FcRn, designed to reduce pathogenic IgG antibodies and block the IgG recycling process
.
The role of the FcRn receptor is to prevent the degradation of IgG, so by preventing the binding of IgG to FcRn, it can lead to faster depletion of IgG antibodies that mediate autoimmune diseases, thereby reducing disease symptoms
.
In January of this year, Zai Lab reached a cooperation with argenx to obtain the development and commercialization rights of this innovative therapy in Greater China, and will be responsible for the global registration clinical research and development of multiple indications of the candidate drug in China
.
This approval is based on the results of the global Phase 3 clinical trial ADAPT, which was published in The Lancet Neurology in July this year
.
The results of the trial showed that Vyvgart reached the primary endpoint of the trial, and 68% of patients receiving its treatment achieved remission, compared with 30% in the placebo group (p<0.
0001)
.
"Patients with systemic myasthenia gravis urgently need new treatment options that can target the underlying pathogenesis
.
" ADAPT clinical trial principal investigator, Dr.
James F.
Howard Jr.
of the University of North Carolina at Chapel Hill School of Medicine said, "Today's approval is for patients This is an important new development for their families
.
It has the potential to reduce the burden of disease and is expected to revolutionize the way we treat diseases
.
"Reference: [1] argenx Announces US Food and Drug Administration (FDA) Approval of VYVGART™ ( efgartigimod alfa-fcab) in Generalized Myasthenia Gravis.
Retrieved December 18, 2021, from https://
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
These patients account for approximately 85% of all gMG patient populations
.
The press release states that Vyvgart is the first FDA-approved neonatal Fc receptor (FcRn) blocker
.
Myasthenia gravis is a rare chronic autoimmune disease
.
Immunoglobulin G (IgG) antibodies disrupt the communication between nerves and muscles, causing weakness and possibly life-threatening muscle weakness
.
More than 85% of patients progress to generalized myasthenia gravis within 18 months after the onset of the disease, which leads to extreme fatigue and difficulty in facial expressions, speech, swallowing, and movement
.
Vyvgart is a "first-in-class" therapy targeting FcRn, designed to reduce pathogenic IgG antibodies and block the IgG recycling process
.
The role of the FcRn receptor is to prevent the degradation of IgG, so by preventing the binding of IgG to FcRn, it can lead to faster depletion of IgG antibodies that mediate autoimmune diseases, thereby reducing disease symptoms
.
In January of this year, Zai Lab reached a cooperation with argenx to obtain the development and commercialization rights of this innovative therapy in Greater China, and will be responsible for the global registration clinical research and development of multiple indications of the candidate drug in China
.
This approval is based on the results of the global Phase 3 clinical trial ADAPT, which was published in The Lancet Neurology in July this year
.
The results of the trial showed that Vyvgart reached the primary endpoint of the trial, and 68% of patients receiving its treatment achieved remission, compared with 30% in the placebo group (p<0.
0001)
.
"Patients with systemic myasthenia gravis urgently need new treatment options that can target the underlying pathogenesis
.
" ADAPT clinical trial principal investigator, Dr.
James F.
Howard Jr.
of the University of North Carolina at Chapel Hill School of Medicine said, "Today's approval is for patients This is an important new development for their families
.
It has the potential to reduce the burden of disease and is expected to revolutionize the way we treat diseases
.
"Reference: [1] argenx Announces US Food and Drug Administration (FDA) Approval of VYVGART™ ( efgartigimod alfa-fcab) in Generalized Myasthenia Gravis.
Retrieved December 18, 2021, from https://
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
