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▎WuXi AppTec Content Team Editor Recently, argenx announced that the subcutaneous injection formulation of efgartigimod has obtained positive data in a phase 3 clinical trial
.
The trial met its primary endpoint of reduced immune globulin G (IgG) levels from baseline in patients with generalized myasthenia gravis (gMG) at 29 days of treatment, in line with the drug's approved intravenous (IV) formulation, Vyvgart (efgartigimod alfa).
-fcab) compared to non-inferiority criteria
.
Based on these results, argenx plans to submit a Biologics License Application (BLA) for the subcutaneous formulation to the U.
S.
FDA by the end of this year
.
Myasthenia gravis is a rare chronic autoimmune disease
.
IgG antibodies disrupt communication between nerves and muscles, causing weakness and potentially life-threatening muscle weakness
.
More than 85% of patients progress to generalized myasthenia gravis within 18 months of onset, leading to extreme fatigue and difficulty with facial expression, speech, swallowing, and mobility
.
Vyvgart, a "first-in-class" therapy targeting the Fc receptor (FcRn), was approved in December last year, making it the first FDA-approved FcRn blocker
.
It is 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
.
Zai Lab has partnered with argenx to acquire the rights to develop and commercialize this innovative therapy in Greater China
.
The subcutaneous injection formulation of Efgartigimod contains recombinant human hyaluronidase PH20 (rHuPH20)
.
Developed by Halozyme Therapeutics, rHuPH20 degrades hyaluronic acid in the body to aid in the penetration and absorption of subcutaneously injected drugs, providing patients with additional treatment options
.
▲argenx's R&D pipeline (Image source: argenx's official website) This phase 3 clinical trial evaluated the pharmacodynamics of efgartigimod subcutaneous injection compared with intravenous infusion preparations in 100 adult patients with gMG
.
The trial met its primary endpoint of non-inferiority criteria (p<0.
0001), with a 66.
4% reduction from baseline in mean total IgG levels at day 29 in the subcutaneous formulation group and 62.
2% in the intravenous formulation group
.
In addition, the trial met other key secondary endpoints consistent with the clinical efficacy results observed in the Phase 3 clinical trial of the intravenous infusion formulation, including Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) improvement in ratings
.
Its safety profile was also consistent with previous studies, and was generally well tolerated, with the most common adverse event being injection site reactions (ISRs)
.
"Each patient with gMG experiences the disease in their own way, including how they manage their symptoms
,
" said trial principal investigator Professor James F.
Howard Jr.
"For years, patients have lacked adequate treatment options, let alone access to treatment options tailored to the unique needs of patients
.
These data, along with the approval of Vyvgart, represent an exciting advance in the management of this debilitating and unpredictable disease, providing patients and physicians with options based on individual needs and preferences.
Treatment options
.
” Reference: [1] Argenx Announces Positive Topline Phase 3 Data From ADAPT-SC Study Evaluating Subcutaneous Efgartigimod for Generalized Myasthenia Gravis.
Retrieved March 22, 2022, from https:// enDisclaimer: The WuXi AppTec content team focuses on introducing the progress of global biomedical health research
.
This article is for information exchange purposes only, and the views in this article do not represent WuXi AppTec's position, nor do they support or oppose the views in the article
.
This article is not Recommended treatment plan
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
The trial met its primary endpoint of reduced immune globulin G (IgG) levels from baseline in patients with generalized myasthenia gravis (gMG) at 29 days of treatment, in line with the drug's approved intravenous (IV) formulation, Vyvgart (efgartigimod alfa).
-fcab) compared to non-inferiority criteria
.
Based on these results, argenx plans to submit a Biologics License Application (BLA) for the subcutaneous formulation to the U.
S.
FDA by the end of this year
.
Myasthenia gravis is a rare chronic autoimmune disease
.
IgG antibodies disrupt communication between nerves and muscles, causing weakness and potentially life-threatening muscle weakness
.
More than 85% of patients progress to generalized myasthenia gravis within 18 months of onset, leading to extreme fatigue and difficulty with facial expression, speech, swallowing, and mobility
.
Vyvgart, a "first-in-class" therapy targeting the Fc receptor (FcRn), was approved in December last year, making it the first FDA-approved FcRn blocker
.
It is 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
.
Zai Lab has partnered with argenx to acquire the rights to develop and commercialize this innovative therapy in Greater China
.
The subcutaneous injection formulation of Efgartigimod contains recombinant human hyaluronidase PH20 (rHuPH20)
.
Developed by Halozyme Therapeutics, rHuPH20 degrades hyaluronic acid in the body to aid in the penetration and absorption of subcutaneously injected drugs, providing patients with additional treatment options
.
▲argenx's R&D pipeline (Image source: argenx's official website) This phase 3 clinical trial evaluated the pharmacodynamics of efgartigimod subcutaneous injection compared with intravenous infusion preparations in 100 adult patients with gMG
.
The trial met its primary endpoint of non-inferiority criteria (p<0.
0001), with a 66.
4% reduction from baseline in mean total IgG levels at day 29 in the subcutaneous formulation group and 62.
2% in the intravenous formulation group
.
In addition, the trial met other key secondary endpoints consistent with the clinical efficacy results observed in the Phase 3 clinical trial of the intravenous infusion formulation, including Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) improvement in ratings
.
Its safety profile was also consistent with previous studies, and was generally well tolerated, with the most common adverse event being injection site reactions (ISRs)
.
"Each patient with gMG experiences the disease in their own way, including how they manage their symptoms
,
" said trial principal investigator Professor James F.
Howard Jr.
"For years, patients have lacked adequate treatment options, let alone access to treatment options tailored to the unique needs of patients
.
These data, along with the approval of Vyvgart, represent an exciting advance in the management of this debilitating and unpredictable disease, providing patients and physicians with options based on individual needs and preferences.
Treatment options
.
” Reference: [1] Argenx Announces Positive Topline Phase 3 Data From ADAPT-SC Study Evaluating Subcutaneous Efgartigimod for Generalized Myasthenia Gravis.
Retrieved March 22, 2022, from https:// enDisclaimer: The WuXi AppTec content team focuses on introducing the progress of global biomedical health research
.
This article is for information exchange purposes only, and the views in this article do not represent WuXi AppTec's position, nor do they support or oppose the views in the article
.
This article is not Recommended treatment plan
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
