Novartis Reports New Phase III Data

Novartis has announced late-breaking results showing omalizumab met all primary and secondary endpoints of a pivotal Phase III safety registration study in chronic spontaneous urticaria (CSU)[1], a chronic and debilitating form of hives with limited approved treatment options[2–4]. 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. Omalizumab is not currently approved or indicated for CSU. 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[1]. Up to 40% of CSU patients fail on antihistamines, even those taking up to four times the approved dose[5]. Antihistamines, at the approved dose, are currently the only licensed treatment for CSU.

"This is encouraging news for people living with CSU, whose quality of life is greatly impacted by this serious disease and who currently have few treatment options," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Novartis is committed to doing all we can for these patients by working to develop an important advance in CSU treatment, where unmet medical need remains high."

Specifically, more than one third of omalizumab-treated patients in the GLACIAL study were completely itch- and hive-free by Week 12, compared with 5% of placebo-treated patients (p<0.001)[1]. 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)[1]. The significant improvements observed with omalizumab were sustained throughout the treatment period up to Week 24[1].

The study also evaluated impact on quality of life, an important measure as up to 80% of patients with CSU suffer negative effects on their quality of life including sleep deprivation and psychological comorbidities such as depression and anxiety[6].

Omalizumab-treated patients also experienced a significant increase in the proportion of days free of deep tissue swelling, also known as angioedema (p<0.001)[1]. 

Omalizumab is being jointly developed by Novartis and Genentech, Inc. for CSU. Regulatory submissions for omalizumab in CSU are on track for later this year.

References

[1] 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, 12:00 pm.

[2] Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria (Hives)." https://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed 14 November 2012.

[3] American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin Allergy Overview." https://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed 14 November 2012.

[4] Casale T, Maurer M, Hsieh HJ, et al. Efficacy and safety of omalizumab in chronic idiopathic/spontaneous urticaria: results from a phase III, randomized, double-blind, placebo-controlled trial (ASTERIA II). American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting. 4611 Late Breaking Oral Abstract I. 25 March 2013, 2:30 pm.

[5] Sánchez-Borges M, Asero R, Ansotegui IJ, et al. Diagnosis and treatment of urticaria and angioedema: a worldwide perspective (position paper). World Allergy Organization Journal. 2012; 5:125–147.

[6] Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317–330.