Xolair (Novartis/Genentech) success in GLACIAL study for Chronic Spontaneous Urticaria

Novartis announced results showing omalizumab met all primary and secondary endpoints of a pivotal Phase III safety registration study in Chronic Spontaneous Urticaria (CSU), a chronic and debilitating form of hives with limited approved treatment options. The data was presented for the first time at the European Academy of Allergy and Clinical Immunology-World Allergy Organization (EAACI-WAO) World Allergy and Asthma Congress 2013 in Milan, Italy. Regulatory submissions for omalizumab in CSU are on track for later this year.

GLACIAL is the second of three pivotal Phase III studies that investigate the efficacy and safety of omalizumab in CSU. The study results supported the efficacy, safety and tolerability of omalizumab in patients with refractory CSU, a chronic and debilitating skin disease with intractable itch and hives. Up to 40% of CSU patients fail on antihistamines, even those taking up to four times the approved dose. Antihistamines, at the approved dose, are currently the only licensed treatment for CSU. Specifically, more than one third of omalizumab-treated patients in the GLACIAL study were completely itch- and hive-free by Week 12, compared to 5% of placebo-treated patients (p<0.001). During the same time period, the proportion of patients with well controlled CSU symptoms (itch, hives) was four times higher in the omalizumab group compared to placebo (52% and 12% respectively, p<0.001). The significant improvements observed with omalizumab were sustained throughout the treatment period up to Week 24.

see Maurer M, Staubach P, Ashby M, et al. The safety and efficacy of omalizumab in chronic idiopathic/spontaneous urticaria (CIU/CSU): results from a Phase III randomized, double-blind, placebo-controlled study. European Academy of Allergy and Clinical Immunology-World Allergy Organization (EAACI-WAO) World Allergy and Asthma Congress annual meeting 2013. Late Breaking Poster. 25 June 2013.