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FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

The Asthma and Allergy Foundation of America (AAFA) is sharing this press release from Novartis to bring you the latest news quickly.


[PRESS RELEASE]

Novartis receives FDA approval of Xolair® (omalizumab) self-injection with prefilled syringe across all indications for appropriate patients

Xolair for self-injection offers healthcare providers and appropriate patients another administration option for more flexibility in managing their treatment

EAST HANOVER, N.J., April 12, 2021 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.

"Today's FDA approval represents an important milestone for Xolair and highlights our continued commitment to innovation for patients since its first approval in 2003," said Victor Bultó, President, Novartis Pharmaceuticals Corporation. "With the new offering of self-injection for Xolair, healthcare providers now have an additional administration option for appropriate patients, which is particularly timely given the COVID-19 pandemic."

Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity (allergic reactions). After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider may determine whether self-injection with Xolair pre-filled syringe by the patient or caregiver is appropriate. The healthcare provider must train the patient or caregiver on the correct subcutaneous injection technique, how to recognize the signs and symptoms of anaphylaxis and how to treat anaphylaxis appropriately, before the first self-injection outside a healthcare setting.

"Expanding treatment options for personalized care and self-management is always welcome news for the patient community," said Kenneth Mendez, CEO and President, Asthma and Allergy Foundation of America. "The possibility of administering FDA-approved treatment outside of the healthcare provider's office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers."

Approximately 460,000 patients have been treated in the US with Xolair since its initial approval in 2003.2 The use of Xolair across allergic asthma, CIU and nasal polyps is based on a well-established efficacy and safety profile which is supported by a robust clinical development program, including 10 Phase III studies.

In the US, Novartis Pharmaceuticals Corporation and Genentech, a member of the Roche Group, work together to develop and co-promote Xolair.

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® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:

  • moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if people have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.
  • nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with nasal polyps under 18 years of age.
  • chronic idiopathic urticaria (CIU, chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CIU under 12 years of age.

XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems.

Please see full Prescribing Information, including Medication Guide for additional Important Safety Information.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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 nearly 16,000 people in the United States. For more information, please visit https://www.novartis.us.

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References

  1. Xolair® Full Prescribing Information. Genentech, Inc.; April 2021.
  2. Data on file. Genentech, Inc.


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

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Comments (3)

Newest · Oldest · Popular

I've been on Xolair injections for 8 months now, and we're doubling my dose since my IgE levels are still very high. Even though the FDA has approved injecting at home, my physician's office is still apprehensive about allowing me to inject at home. I have Epi pens and I'm ready to make the switch.  It will save me an hour round trip, and $65 per injection.

Is it typical for doctor's offices to be nervous about switching?

katalinfrog

If you are currently on Xolair or considering it, what are your thoughts about self injections? Excited that this will make things more convenient? Apprehensive about doing the shots at home instead of a clinic? Join the discussion!

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