Safety: Well established safety profile

Well established safety profile

Safety evalutated in >15,600 subjects receiving Xolair® in clinical programs.2

Xolair® has >819,419 patient years' experience, since US approval in 2003, and EU approval in 20052-4**

  • In the US, Xolair® is licensed for adults and adolescents (≥12 years of age) with moderate to severe allergic asthma3
  • In the EU, Xolair® is licensed for adults and adolescents (≥6 years of age) with persistent allergic asthma4

Xolair® is now approved in >90 countries for asthma, including the EU2 and >80 countries for CSU/CIU.

Model is a hypothetical patient profile, for illustrative purposes only

*Data from ASTERIA II; two other phase III studies (ASTERIA I and GLACIAL) were also conducted to assess efficacy and safety of Xolair® in inadequately controlled CSU patients

**This patient population includes patients suffering from Chronic Spontaneous Urticaria (CSU) as well as Severe Allergic Asthma (SAA).

Xolair® 300mg vs. baseline at 12 weeks; p<0.001 vs. placebo.

Xolair® is also available as a lyophilized formulation

References: 1. Maurer M, et al. N Engl J Med 2013;368:924-935. 2. Periodic Safety Update Report (PSUR) version 22. 3. Xolair® US Product Information 2014. 4. Xolair® Summary of Product Characteristics 2016. 5. Maurer M et al. Allergy 2011;66:317-330. 6. Weller K, et al. J Eur Acad Dermatol Venereol 2013;27:43-50

NP4 code: GLDEIM/IGE025E/0181

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