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Classified in: Health, Science and technology, Covid-19 virus
Subject: Product/Service

FDA Accepts Application for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications


Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. 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 U.S. 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 U.S., 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).

"Due to the COVID-19 pandemic, there is an urgent need to provide self-administration of Xolair to our patients, particularly those who are considered high-risk for severe illness," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We look forward to working closely with the FDA to make Xolair self-administration available as quickly as possible to provide patients with greater flexibility to manage their treatment needs."

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 U.S. with Xolair since its initial approval for allergic asthma in 2003. 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.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

About Allergic Asthma and Chronic Idiopathic Urticaria

Asthma is a serious and chronic lung disease affecting an estimated 24 million people in the U.S. 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.

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

About Xolair

Xolair 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.

Xolair U.S. Indications

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

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

Important Safety Information

The most important information patients should know about XOLAIR is that a severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

The patient's healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after the patient's injection. The patient's healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider's office or treatment center.

Patients must not receive XOLAIR if they are allergic to omalizumab or any of the ingredients.

Before receiving XOLAIR, patients must tell their healthcare provider about all of their medical conditions, including if they:

Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Receiving XOLAIR

Possible Side Effects of XOLAIR

XOLAIR may cause serious side effects, including:

The most common side effects of XOLAIR:

These are not all the possible side effects of XOLAIR. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide at http://www.xolair.com for additional Important Safety Information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.


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