Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption

Novartis International AG / Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• OPTIMA Phase IIIb data re-confirm that almost two thirds of patients treated with Xolair 300 mg for 6 months are well-controlled[1]
   

Should a treatment pause be necessary, data showed almost 90% of chronic spontaneous urticaria (CSU) patients - previously well controlled - regained effective symptom control within 12 weeks of re-treatment on Xolair[2]
 

Previous studies have shown that inadequately controlled CSU has a major impact on sleep, social lives and work[3]

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Basel, September 16, 2017 - Novartis, a global leader in Immunology & Dermatology, announced today new data showing almost 90% of chronic spontaneous urticaria (CSU) patients who responded well to initial Xolair^® (omalizumab) treatment regained symptom control within 12 weeks of Xolair retreatment following a treatment interruption, based on Weekly Urticaria Activity Score (UAS7) criteria (UAS7=<6)[2]. Findings were presented at the 26^th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland.

CSU is a distressing skin condition that appears spontaneously and causes persistent hives and/or painful deeper swelling of the skin for 6 weeks or more[4]. International treatment guidelines state that the goal of treatment for CSU is the complete elimination of symptoms[5],[6]. For CSU patients who have not successfully controlled their symptoms with H1 antihistamine (H1-antagonists) treatment, Xolair can reduce or eliminate symptoms[4],[7],[8]. Xolair is the first and only approved therapy for CSU patients who show an inadequate response to H1 antihistamines.

"CSU can have a severe impact on quality of life. Its unpredictable nature, combined with the fact that some physicians mistakenly dismiss it as a trivial condition, can mean patients do not get adequate treatment with effective and long-term symptoms control," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "If for some reason treatment has been interrupted, these data give patients and physicians confidence that it's possible to regain effective symptom control with Xolair."