FDA Approves Self-Injectable Formulation of Xolair

The FDA has approved a self-injectable formulation of Xolair for appropriate patients with moderate to severe persistent allergic asthma, nasal polyps or chronic idiopathic urticaria, according to the manufacturers.

“Expanding treatment options for personalized care and self-management is always welcome news for the patient community,” Kenneth Mendez, CEO and president of the Asthma and Allergy Foundation of America, said in a press release. “The possibility of administering FDA-approved treatment outside of the health care provider’s office, but still guided by that health care provider, may reduce barriers to care for patients and their caregivers.”

Xolair (omalizumab, Genentech and Novartis) is a biologic agent that has been approved in the United States since 2003, according to press releases from the manufacturers. It is used to treat moderate to severe persistent asthma in patients aged 6 years and older whose condition is not well-controlled with inhaled corticosteroids; nasal polyps in patients aged 18 years and older whose condition is not well-controlled with nasal corticosteroids; and chronic idiopathic urticaria in patients aged 12 years and older whose condition is not well-controlled with H1 antihistamine treatment.

The self-injectable formulation is indicated for patients with no previous history of anaphylaxis. Before they can self-administer the prefilled syringe, providers must observe patients for hypersensitivity after at least three injections in a health care setting, according to the press releases. After safety has been established, the provider can determine whether the self-injectable formulation is appropriate for the patient. If so, the provider must train the patient or caregiver how to administer the injection outside a health care setting, identify signs of anaphylaxis and appropriately treat anaphylaxis, the releases said.


Business Wire. FDA approves Xolair (omalizumab) prefilled syringe for self-injection across all indications. https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-of-xolair-omalizumab-self-injection-with-prefilled-syringe-across-all-indications-for-appropriate-patients-301266937.html