Prescribing information

 

   

  • Simple dosing of 300 mg every 4 weeks1
  • Directly targets and binds to IgE,1–3 preventing histamine release.2,3

 

Preview of dosing and self-administration resources

82% of patients responded to treatment at 12 weeks
(vs 59% placebo, p<0.001)4‡
34% of patients were itch and hive-free at 12 weeks
(vs 5% placebo, p<0.001)

Preview of mode of action video

73% reduction in DLQI from baseline at 12 weeks
(vs 22% placebo, p<0.001)5,6¥

Preview of Professor Stephen Holgate video

>1.3 million patient-years of market experience across CSU and SAA7

 

*Post hoc analysis of phase 3 studies (ASTERIA I & II, and GLACIAL), demonstrated clinically meaningful improvements in quality of life (measured using DLQI) in patients with CSU.8

Data from a randomised, double-blind, placebo-controlled, parallel group study of 336 patients aged 12–75 years with CSU for 6 months, itch and hives for >6 consecutive weeks before enrolment despite therapy with H1-AH ± H2-AH ± LTRAs, and a UAS7 16. Mean UAS7 at baseline was 31.2 for Xolair and 30.2 for placebo. Mean DLQI at baseline was 13.8 for Xolair and 13.0 for placebo (for the modified intention-to-treat population).
Exploratory endpoint: Proportion of patients achieving MID in UAS7 (reduction in UAS7 from baseline of 11 points).
§Secondary endpoint, UAS7=0.
¥Additional efficacy endpoint. Absolute reduction of −9.7 (vs 5.1 placebo) in mean DLQI (observed data, p<0.001).

Indication: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment.1

CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; H1-AH, H1-antihistamine; IgE, immunoglobulin E; MID, minimal important difference; SAA, severe allergic asthma; UAS7, urticaria activity score (seven days).

References

  1. Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
  2. Chang TW et al. J Allergy Clin Immunol 2015;135(2):337–342.
  3. Kaplan AP et al. Allergy 2017;72(4):519–533.
  4. Novartis data on file XSU15-R002. Proportion of UAS7 MID responders at week 12 – GLACIAL study.
  5. Kaplan A et al. J Allergy Clin Immunol 2013;132(1):101–109.
  6. Casale TB et al. J Allergy Clin Immunol Pract 2015;3(5):743–750.e1.
  7. Novartis data on file. Periodic Safety Update Report (PSUR) 2019.
  8. Finlay AY et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
XSU20-C008 July 2020.
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