Prescribing information

 

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Xolair was the first biologic to receive a licence for the treatment of patients with severe allergic asthma (SAA).1,2  

 

Discover the journey of Xolair

Use the interactive widget below to discover the journey of Xolair from 2005 through to the present day, which has seen over 1.3 million patient treatment years of exposure in the real world.†2 Along the way, click on the ‘Did you know’ links to find out some short facts about Xolair that you may not know.

Xolair timeline

Xolair’s heritage

Watch this short video highlighting the major milestones in Xolair’s severe persistent allergic asthma journey in the UK, from the results of the first pivotal trial in 2005 to its innovation awards, licence approvals, guideline recommendations and real world evidence to date (2021).

Video link

 

 

Xolair interactive timeline

Xolair’s heritage

 

Indication:23
Xolair should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.

In adults and adolescents (12 years of age and older): Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

In children (6 to <12 years of age): Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control.23

*In a pooled analysis across six studies in patients with severe allergic asthma, omalizumab (n=1,342) consistently improved quality of life, delivering significantly greater improvements in the asthma quality of life questionnaire (AQLQ) overall score compared with placebo/control (n= 1,206) [1.01 vs 0.61; p<0.001]; and in the proportion of patients in the pooled population recording a ≥0.5-point improvement in AQLQ overall score [66.3% omalizumab vs 52.4% placebo control p<0.001].24
Exposure in patients with SAA and in patients with chronic spontaneous urticaria.2
Please refer to the SMC website for the full SMC guidelines for Xolair.
The first 3 doses are always given by or under the supervision of a HCP. It is important to properly train the patient on how to inject this medicine before self-administration. A caregiver may also give the patient the Xolair injection after he or she has received proper training. Refer to the SmPC for further information regarding self-administration.1
§
Xolair crosses the placental barrier. If clinically needed, the use of Xolair may be considered during pregnancy.

FEV, forced expiratory volume; GETE, global evaluation of treatment effectiveness; HCP, healthcare professional; IgE, immunoglobulin E; INC, intranasal corticosteroids; NICE, National Institute for Health and Care Excellence; PEF, peak expiratory flow; RCT, randomised controlled trial; SAA, severe allergic asthma; SMC, Scottish Medicines Consortium.

 

References:

  1. European Medicines Agency Xolair Scientific Discussion. Available at: https://www.ema.europa.eu/en/documents/scientific-discussion/xolair-epar.... (Accessed March 2022).
  2. Bousquet J et al. J Allergy Clin Immunol Pract 2021;9(7):2702–2714.
  3. Humbert M et al. Allergy 2005;60(3):309–316.
  4. Pharmafield (2006). Innovation rewarded at Prix Galien 2006. Available at: https://pharmafield.co.uk/in_depth/innovation-rewarded-at-prix-galien-2006/. (Accessed March 2022).
  5. Scottish Medicines Consortium (2007). Omalizumab 150mg powder and solvent for injection (Xolair®). Available at: https://www.scottishmedicines.org.uk/media/2079/259_06_omalizumab_xolair.... (Accessed March 2022).
  6. NICE (2007). Omalizumab for severe persistent allergic asthma. Available at: https://www.respiratoryfutures.org.uk/media/1028/ta133-guidance.pdf. (Accessed March 2022).
  7. Brusselle G et al. Respir Med 2009;103(11):1633–1642.
  8. EMEA (2009). Committee for medicinal products for human use post-authorisation summary of positive opinion for XOLAIR. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summ.... (Accessed March 2022).
  9. Kulus M et al. Curr Med Res Opin 2010;26(6):1285–1293.
  10. SMC (2010). Omalizumab 150 mg powder and solvent for solution for injection (Xolair®) (No: 611/10). Available at: https://www.scottishmedicines.org.uk/media/2078/omalizumabxolair_abbrevi.... (Accessed March 2022).
  11. Bousquet J et al. Allergy 2011;66(5):671–678.
  12. Hanania NA et al. Ann Intern Med 2011;154(9):573–582.
  13. Tzortzaki E et al. Pulm Pharmacol Ther 2012;25:77–82.
  14. Deschildre A et al. Eur Respir J 2013;42:1224–1233.
  15. Barnes N et al. J Asthma 2013;50(5):529–536.
  16. NICE (2013). Omalizumab for treating severe persistent allergic asthma. Technology appraisal guidance 278. Available at: https://www.nice.org.uk/guidance/ta278/resources/omalizumab-for-treating... (Accessed March 2022).
  17. Long A et al. J Allergy Clin Immunol 2014;134:560–567.
  18. Niven RM et al. BMJ Open 2016;6:e011857.
  19. Humbert M et al. Eur Respir J 2018;51:1702523.
  20. Novartis (2018). Novartis receives European Commission approval for self-administration of Xolair® across all indications. Available at: https://www.novartis.com/news/media-releases/novartis-receives-european-.... (Accessed March 2022).
  21. Namazy JA et al. Allergy Clin Immunol 2020;145:528–536.
  22. Novartis (2020). Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps. Available at: https://www.novartis.com/news/media-releases/novartis-receives-ec-approv.... (Accessed March 2022).
  23. Xolair® (omalizumab) Summary of Product Characteristics.
  24. Chipps B, et al. Curr Med Res Opin 2006;22(11):2201-2208.
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UK | April 2022 | 184852
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