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Novartis Reports Update of ligelizumab (QGE031) in P-III PEARL 1 & 2 Studies for the Treatment of Chronic Spontaneous Urticaria

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Novartis Reports Update of ligelizumab (QGE031) in P-III PEARL 1 & 2 Studies for the Treatment of Chronic Spontaneous Urticaria

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  • The P-III (PEARL 1 & 2) studies evaluate the efficacy and safety of ligelizumab vs PBO in 2,000+ adult and adolescent patients aged ≥12yrs. with CSU who remain symptomatic despite H1-antihistamine treatment across 48 countries
  • The studies met its 1EP of superiority for ligelizumab compared to PBO @12wks. but not in comparison with omalizumab. The results are expected in H2’22
  • Ligelizumab is a high-affinity, monoclonal anti-Ig E Ab that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company has initiated the P-III studies of remibrutinib (LOU064) which has previously shown rapid and effective CSU disease control

Ref: Novartis Image: Novartis 

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