AstraZeneca Seeks Expanded Use For Soliris As First Targeted Therapy For Pediatric Patients With Autoimmune Neuromuscular Disease
Portfolio Pulse from Vandana Singh
The European Union has recommended AstraZeneca's Soliris for marketing authorization for expanded use in refractory generalized myasthenia gravis (gMG) in children and adolescents. If approved, Soliris would be the first targeted therapy for pediatric patients with refractory gMG in the EU.

June 26, 2023 | 12:29 pm
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Last week, the FDA approved Argenx's Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine receptor antibody positive, representing approximately 85% of the total gMG population.
The FDA approval of Argenx's Vyvgart Hytrulo for gMG in adult patients is a positive development for the company. As it targets approximately 85% of the total gMG population, it has the potential to capture a significant market share and boost Argenx's revenues.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 50
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AstraZeneca's Soliris recommended for marketing authorization in the EU for expanded use in pediatric patients with refractory gMG, potentially becoming the first targeted therapy in the EU.
The recommendation for marketing authorization of Soliris for expanded use in pediatric patients with refractory gMG in the EU is a positive development for AstraZeneca. If approved, it would be the first targeted therapy for this patient group in the EU, potentially increasing the demand for Soliris and boosting AstraZeneca's revenues.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100