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New indication for Xolair approved by the European Commission for treatment in chronic spontaneous urticaria patients

Novartis has announced that (EC) has approved the use of Xolair® as an add-on therapy for the treatment of chronic (CSU) in adult and adolescent (12 years and above) patients, who do not respond to the current mainstay of therapy, H1 . The approved dose in CSU is 300 mg administered by subcutaneous injection once every four weeks. Prescribers are advised to periodically reassess the need for continued therapy. Clinical trial experience of treatment beyond six months in this indication is limited.

CSU is thought to affect between 318,000 and 630,000 people in the UK at any given time.2,3 CSU is a severe and distressing skin condition characterised by red, swollen, itchy and painful hives on the skin that spontaneously present and reoccur for more than six weeks.2 Over a third of CSU patients also experience angioedema, a swelling in the deep layers of the skin.1 Negative effects of CSU on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety.2,4 Until now, CSU has been difficult to manage with over half of CSU sufferers not responding to the only licensed treatments, H1 antihistamines.1,2

“Omalizumab has real potential to revolutionise the treatment and management of chronic spontaneous urticaria. This new indication for omalizumab as add-on therapy allows GPs the option to refer patients, whose symptoms are not relieved with licensed doses of antihistamines, on to a specialist knowing that there is now an approved treatment with proven efficacy,” said Dr Nuala Lynch, GP with a special interest in Allergy, Hook & Hartley Wintney Medical Partnership, Hampshire.

The EU approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion on ®, which was adopted based on positive and consistent results from three pivotal placebo-controlled clinical trials (ASTERIA I, ASTERIA II and GLACIAL) that involved nearly 1,000 patients with CSU not responding to H1 antihistamine treatment.5-7 Xolair® 300 mg met all primary and pre-specified secondary endpoints across these studies, which showed Xolair® significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.5-7

Quality of life was also significantly improved for patients treated with Xolair® 300 mg across the Phase III study programme.5-7 In these studies, the incidence and severity of adverse events (AEs) was similar between Xolair® and placebo groups.5-7

Results from the three pivotal registration studies for Xolair® in CSU were announced in 2013:

  • For Xolair® 300 mg the primary efficacy endpoint, the change in weekly Itch Severity Score (ISS) from baseline to week 12, was met in both ASTERIA I and ASTERIA II.5,6

  • In GLACIAL, primarily a safety study, Xolair® 300 mg met all efficacy endpoints.7

Secondary endpoint highlights from these studies that have been previously reported include:

  • In the ASTERIA II study, 44% of patients receiving Xolair® 300 mg were itch- and hive-free after 12 weeks of treatment (p<0.0001).5

  • In the ASTERIA I study, Xolair® 300 mg treated patients experienced a rapid reduction in itch and hives as early as week one, with the therapeutic benefit sustained over 24 weeks of active treatment (p<0.0001).6

  • In the GLACIAL study, more than half of patients who had failed multiple therapies including H1 antihistamines (at up to four times the approved dose) and H2 antihistamines and/or leukotriene receptor antagonists (LTRAs) had their symptoms eliminated or suppressed with Xolair® 300 mg (p<0.001).7

Xolair® has already been approved for the treatment of CSU in five countries around the world. Regulatory reviews are currently ongoing in more than 20 countries, including the US, Canada, Australia and Switzerland.

Xolair® is being jointly developed for CSU by Novartis and Genentech, Inc.


1. 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.

2. 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.

3. Population Estimates for UK, England and Wales, Scotland and Northern Ireland, Mid-2011 and Mid-2012. Office of National Statistics. [Accessed February 2014].

4. O’Donnell BF, Lawlor F, Simpson J, et al. The impact of chronic urticaria on the quality of life. British Journal of Dermatology. 1997; 136(2): 197-201.

5. Maurer M, Rosén K, Hsieh, HJ, et al. Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. New England Journal of Medicine. 2013; 368: 924-35.

6. Maurer M. Phase III randomized, double-blind, placebo-controlled study evaluating efficacy and safety of omalizumab in H1 antihistamine-refractory chronic idiopathic/spontaneous urticaria. European Academy of Dermatology and Venereology (EADV) annual meeting 2013. Oral Presentation. 5 October 2013, 11:30 a.m.

7. Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. Journal of Allergy and Clinical Immunology. 2013 Jul; 132(1):101-9.

8. European Medicines Agency. Omalizumab (XOLAIR®). CHMP opinion (EPAR ref. EMA/CHMP/20684/2014) Available at: www.ema.europa.eu. Accessed February 2014.

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