Genentech and Novartis Win FDA Approval for Self-Injectable Form of Xolair


The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.

On Monday, the FDA greenlit the supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved U.S. indications. Xolair is the only biologic approved in the U.S. designed to target and block immunoglobulin E (IgE) for the treatment of people living with moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.  

Levi Garraway, Roche’s chief medical officer and head of Global Product Development, said the new indication for Xolair reflects the commitment of both Genentech and Novartis to continue developing Xolair as a treatment for people who have allergic and inflammatory conditions.

“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,” Garraway said in a statement.

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The ongoing COVID-19 pandemic demonstrated a need for patients to be able to provide their own self-injection of Xolair, the companies said. 

Xolair, which was most recently approved in December for the treatment of nasal polyps, is an antibody that blocks IgE, which minimizes the release of mediators throughout the allergic inflammatory cascade. Other indications Xolair has been approved for in the U.S. include moderate to severe persistent asthma in people six years of age and older whose asthma symptoms are not well controlled with corticosteroids, and chronic idiopathic urticarial, chronic hives without a known cause, in patients 12 and older who have hives that are not controlled with H1 antihistamine treatments. 

Kenneth Mendez, president and chief executive officer of the Asthma and Allergy Foundation of America, said expanded treatment options for personalized care are always appreciated by the patient community.  

“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,” Mendez said in a statement. 

There are several safety precautions in place before a patient can begin self-treatment with a Xolair prefilled syringe. According to Genentech and Novartis, patients must not have a prior history of anaphylaxis. A healthcare provider must closely watch them for at least three injections to ensure there are no allergic reactions. 

Safety protocols also say that after therapy with the self-injecting mode has begun and is safely established in a healthcare setting, a healthcare provider may determine whether self-injection with a Xolair prefilled syringe by the patient or a caregiver is appropriate. Healthcare providers must train the patient or caregiver on the correct subcutaneous injection technique in recognizing the signs and symptoms of anaphylaxis and treat anaphylaxis appropriately before the first self-injection outside a healthcare setting.


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