FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application for Xolair(R) (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. 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 approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during 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 prefilled syringe by the patient or a 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 U.S. with Xolair since its initial approval in 2003. The use of Xolair across allergic asthma, CIU and nasal polyps is based on its well-established efficacy and safety profile and supported by a robust clinical development program, including 10 Phase III studies.

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

About Xolair

In the U.S., 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(R) (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.

IMPORTANT SAFETY INFORMATION

What is the most important information patients should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when a patient receives 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. Patients must go to the nearest emergency room right away if they have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

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

Patients should not receive and use XOLAIR if they are allergic to omalizumab or any of the ingredients in XOLAIR.

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

  • have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex
  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic re