Associated tags: Patient, GMG, Safety, Lancet Neurology, The Lancet, ADAPT, Pharmaceutical industry, Acetylcholine receptor, Euronext, Hair, Health Canada, Neurology, Alfa Romeo, SMC, NICE, Healthcare Improvement Scotland, MHRA, National Institute for Health and Care Excellence, Neonatal Fc receptor, Immunoglobulin G, University Health Network
Locations: EUROPE, NORTH AMERICA, JAPAN
Retrieved on:
Thursday, September 21, 2023
Hair,
University,
Lancet Neurology,
FC,
Muscular dystrophy,
GMG,
Efgartigimod alfa,
Netherlands,
Sale,
Muscular Dystrophy Canada,
Euronext,
Patient,
University of Toronto,
Division,
ADAPT,
Immunoglobulin G,
SE,
University Health Network,
Acetylcholine receptor,
Neonatal Fc receptor,
Health Canada,
The Lancet,
Pharmaceutical industry,
Neurology With this regulatory milestone, VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada.
Key Points:
- With this regulatory milestone, VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada.
- “There continues to be a significant unmet medical need for people living with gMG, who face debilitating muscle weakness and mobility issues.
- The gMG community in Canada has long awaited new effective treatment advancements for this rare condition.
- “Today is an important day for us as we deliver on our commitment to the gMG community to make VYVGART available to patients in Canada,” said John Haslam, General Manager argenx Canada.
Retrieved on:
Wednesday, March 15, 2023
Alfa Romeo,
SMC,
Lancet Neurology,
NICE,
ADAPT,
Healthcare Improvement Scotland,
Euronext,
Patient,
MHRA,
National Institute for Health and Care Excellence,
Acetylcholine receptor,
The Lancet,
Health care,
GMG,
Pharmaceutical industry “We are pleased to announce this latest regulatory approval of VYVGART, another exciting advancement toward our vision of making our innovation available to as many patients as possible," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
Key Points:
- “We are pleased to announce this latest regulatory approval of VYVGART, another exciting advancement toward our vision of making our innovation available to as many patients as possible," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
- Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle2.
- There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p
- Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.
