AstraZeneca PLC on Thursday said phase 3 data regarding its investigational inhibitor gefurulimab met its primary endpoint in myasthenia gravis activities of daily living.
The Cambridge, England-based pharmaceutical company said gefurulimab demonstrated improvement at week 26 compared to placebo, with a clinically meaningful improvement observed as early as week one, and sustained through week 26.
Generalised myasthenia gravis is a rare autoimmune disorder characterised by loss of muscle function and severe muscle weakness.
‘Findings from PREVAIL offer valuable insight into how early and sustained complement inhibition with gefurulimab may translate into meaningful, functional improvement for people living with gMG. Improvements reflected in both patient- and physician-reported outcome measures further underscore the clinical relevance of these results. As one of the largest global phase III trials in patients with AChR-Ab+ gMG, PREVAIL data reflect our commitment to advancing rigorous, patient-centred science that can transform care for people living with this debilitating and unpredictable disease worldwide,’ said Gianluca Pirozzi, head of Development, Regulatory & Safety, Alexion, AstraZeneca Rare Disease.
AstraZeneca shares were down 0.2% at 12,520.00 pence each on Friday morning in London.
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