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PRESS RELEASE

Novartis announces FDA filing acceptance of Xolair® (omalizumab) prefilled syringe for self-administration across all indications

• If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs
• Filing acceptance is based on the well-established efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria
  
  

EAST HANOVER, N.J., Aug. 13, 2020 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) accepted the company's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021. In the US, Xolair is currently approved for administration by a healthcare provider in a healthcare setting, and is the only approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU).

"Today's FDA filing acceptance of Xolair is a big step forward for people living with IgE-mediated conditions," said Victor Bultó, President, Novartis Pharmaceuticals Corporation. "If approved, self-administration of Xolair would offer a new, convenient and flexible treatment administration option for patients and healthcare providers, which builds on the proven legacy, safety profile and efficacy of Xolair over the last 17 years of real-world use. This is in line with Novartis' strong heritage of innovation and ongoing commitment to reimagining medicine and understanding the continually changing needs of patients and healthcare providers."

If approved, once Xolair therapy has been established and closely observed by a healthcare provider, self-administration of Xolair prefilled syringe outside of a healthcare setting by a patient or caregiver may be deemed appropriate by the healthcare provider for select patients. In those instances, the patient or caregiver would be trained by a healthcare provider in the correct subcutaneous injection technique and recognition of the early signs and symptoms of anaphylaxis.

Approximately 460,000 patients have been treated in the US with Xolair since its initial approval for allergic asthma in 2003.1 The use of Xolair in allergic asthma and CIU is supported by a robust clinical development program, including eight Phase III studies. Independent clinical studies involving patients with allergic asthma and CIU on Xolair treatment suggest that Xolair may be self-administered with proper training and monitoring.2 In the US, Novartis Pharmaceuticals Corporation and Genentech work together to develop and co-promote Xolair.

Xolair is the only IgE blocking biologic available for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

The FDA filing acceptance follows the European Commission's approval for Xolair self-administration (or administration by a trained caregiver) for approved indications in December 2018.  

About Allergic Asthma and Chronic Idiopathic Urticaria

Asthma is a serious and chronic lung disease affecting an estimated 24 million people in the US.3,4 It causes swelling and narrowing of the airways, making breathing difficult. Allergic asthma, the most common form of asthma, accounts for approximately 60 percent of asthma cases in adults.5,6

Chronic idiopathic urticaria (CIU) is a skin condition that can cause hives and severe itch that can last many months and years.7 CIU is characterized by hives that spontaneously occur without an identifiable cause, and recur for six weeks or more.8 It is estimated that approximately 1.5 million people in the US have CIU.7,9

About Xolair® (omalizumab) 

Xolair (omalizumab) is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. 

An injectable prescription medicine, Xolair is approved for the treatment of moderate-to-severe or severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005. Xolair is approved for the treatment of chronic spontaneous urticaria in over 80 countries including the European Union and for chronic idiopathic urticaria (CIU), as it is known in the US and Canada. Xolair has over one million patient years of exposure. In addition, a liquid formulation of Xolair in prefilled syringes has been approved in the US, EU and more than 10 countries outside of the EU, including Canada and Australia. The self-administration indication for Xolair in prefilled syringes was also approved in the EU in 2018. Outside the US, Novartis markets Xolair and records all sales and related costs. 

Xolair US Indications 
Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat: 

• Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens.
• Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.
  
  

Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus. 

About Novartis

Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of Novartis – is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs about 15,000 people in the United States. For more information, please visit https://www.novartis.us.

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References
1. Data on file. Genentech, Inc.
2. Data on file. Genentech, Inc.
3. Centers For Disease Control and Prevention. Most recent asthma data. Updated May 2018. Accessed June 24, 2020. https://www.cdc.gov/asthma/most_recent_data.htm
4. American Academy of Allergy, Asthma & Immunology (AAAAI). Asthma definition. Accessed June 24, 2020. https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/asthma
5. American Academy of Allergy, Asthma & Immunology (AAAAI). Allergic asthma definition. Accessed June 24, 2020. https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/allergic-asthma
6. Arbes SJ, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: Results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120:1139-1145.
7. 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.
8. Khan D. Chronic urticaria: standard management and patient education. UpToDate. Updated September 19, 2013. Accessed July 5, 2018. https://www.uptodate.com/contents/chronic-spontaneous-urticaria-standard-management-and-patient-education#H12466492
9. US Census Bureau. QuickFacts United States. Population estimates, July 1, 2017. Accessed July 5, 2018. https://www.census.gov/quickfacts/fact/table/US/PST045217 

Novartis Media Relations
E-mail: media.relations@novartis.com

Jamie Bennett
Director, US Media Relations
+1 862-217-3976
jamie.bennett@novartis.com